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9302 Lee Highway • Suite 700 • Fairfax, VA 22031 1-571-490-8409 www.peri.org PAGE 1

The Pharmaceutical Education & Research Institute, Inc. SPRING 2017 CATALOG PAGE 2

- To optimize the effectiveness of those involved in the development, review, and approval

processes for health care products through our education and training programs; - To foster professional growth through training and the sharing of information and

knowledge in the research, development, manufacturing, marketing, and post-marketing surveillance of health care products; and

- To enhance the professional effectiveness of our constituencies by providing training and

accredited continuing education for physicians, nurses, pharmaceutical professionals and others, that meets or exceeds established standards.

Adopted by the PERI Board of Directors in November 2000.

William J. DeLorbe, PhD Chairman Owner The DeLorbe Group, LLC Jonca Bull Director, Office of Minority Health Office of the Commissioner US Food and Drug Administration C. Robert Eaton President and CEO Your Bio Team David I. Goldsmith, MD President & Senior Consultant Goldsmith Pharmacovigilance and Systems

Judith K. Jones, MD, PhD President Pharmaceutical Education & Research Institute, Inc. (PERI) Anthony J. Piraino, MD, PhD, FACP Higher Education Professional Retired Industry Executive Jean-Louis Saillot, MD President JLS Pharma Consulting Claudio P. Spiguel, PhD Retired Higher Education Professional Industry Executive

Gillian R. Woollett, MA, D.Phil Senior Vice President FDA Regulatory Policy Avalere Health

OUR MISSION

OUR BOARD OF DIRECTORS


Introduction Mission Statement 2 Board of Directors 2 Message from the President 4 Continuing Education 5 Certificate Programs 5 Open Courses 6 ▪ Project Management 7 ▪ Regulation of Marketing 8 ▪ Biologics & Biosimilars 9 ▪ Basic Drug Development 10 ▪ Ethics in the Pharmaceutical Industry 11 Blended Online Programs & Webinars 12 ▪ Working with CCDS and Core Safety 12 ▪ Basic Pharmacology Blended Course 13 Corporate Education Programs 14 Webinars & Blended Education 15 Program Topics ▪ Fundamentals Programs 16 ▪ Oncology 16 ▪ Quality Assurance/Compliance 17 ▪ Project Management 17 ▪ Clinical Research & Development 18 ▪ Regulatory Affairs 18 ▪ Fundamental Online Education 19 Distance Education 20 Program Topics ▪ Applied Good Clinical Practices (GCP) 21 ▪ Decision Points in Drug Development 22 ▪ Regulatory Context for Conducting 23 Clinical Trials ▪ Implementing a Clinical Trial Program 24 ▪ Ensuring Subject Protection & Scientific 25 Integrity ▪ Pharmacology Online 26 ▪ Statistical Concepts Used in Clinical Trials 27 Archived Webinars 28 Treating Cancer: Immuno-Oncology Series 28 Complete Registration Policies 29 Registration Form 30

CORPORATEEDUCATION

WEBINARSERIES

OPENCOURSES

DISTANCEEDUCATION

TABLE OF CONTENTS


The Pharmaceutical Education and Research Institute, Inc. (PERI) is pleased to present the new Spring 2017 Catalog that details our Open, Corporate, and Online Education courses, including webinars and blended programs. We are now in our 28th year of providing accredited education to professionals in the global biopharmaceutical and medical product sectors. To ensure our education is up-to-date and tracks sector initiatives, PERI works with experienced faculty and curriculum committee members to survey the continually changing terrain facing professionals. We are in an exciting new era marked by a burgeoning array of scientific developments - biomarkers, personalized medicine with the application of genomics, new vaccines, and drug-device combinations to name a few. This is coupled with changes in the shrinking global regulatory environment. As new scientific developments, regulations and policies emerge, the need for a well-informed and updated workforce grows. PERI strongly believes that education for this sector’s professionals is critical to support the rapid advances in this area of applied, regulated science. Today, education is an expected part of professional development to assure a company’s competitive advantage in the world marketplace. The global economic challenges make both corporations and individuals sensitive to value in education. PERI is proud to have been on the forefront in addressing this core requirement. PERI is also somewhat unique in that our courses require active participation and problem solving. This feature distinguishes our format from the more passive lecture or webinar, and we believe it is an important strength of our programs. In addition to our core education courses, PERI is prepared to meet our learners’ diverse needs by offering more specialized subjects, including more one-day special topic courses and targeted webinars. All of these can be brought to your site, as needed. New topics are being added throughout the year. Please check our web site http://www.peri.org for the latest information. We at PERI are committed to providing programs that provide timely knowledge taught by experienced and knowledgeable faculty. We are always interested in hearing from those of you who would like to serve as faculty or developers of new courses. On behalf of all the PERI Staff, our Board and many supportive faculty members, I thank you for your interest! We hope you will have an opportunity to take one or more courses this year. Thanks and we look forward to meeting you at a course in the coming months! Sincerely, Judith K. Jones, MD, PhD President, PERI

MESSAGE FROM THE PRESIDENT


PERI is pleased to make continuing education credit available to you for participation in distance education and open courses, as well as corporate programs. Applying for credit is simple; to receive credit, you must participate in the entire program and submit a Continuing Education Application. NOTE: An additional $35 fee applies for students applying for credit. To receive credit for an online Distance Education (DE) course, you must complete all course requirements (i.e., quizzes and/or case studies) and evaluation, and submit an email request for DE credit. Upon confirmation of the completed requirements, your credit will be mailed.

PERI, Inc. is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

PERI, Inc. is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Note: Please check our web site for the most current information on our continuing education offerings.

Continue your education with PERI’s Professional Certificate Programs! These advanced education programs for working professionals offer additional specialized knowledge specific to careers in the biopharmaceutical industry. Currently PERI offers four certificate programs, which can be awarded after completion of a combination of four core and elective courses. These programs are tailored to busy working professionals, as certain certificates may be earned totally online, and students have up to five years to complete the required courses for their education certificate. These educational tracks are specifically and expertly designed to enhance the knowledge and skills needed for a student’s particular job function. The certificate documents an individual’s professional development and helps prepare them for future endeavors. PERI certificate programs are modeled after graduate-level certificates from colleges and universities; they do not offer certification. PERI’s certificate programs allow students to personalize a path just right for them. Many of the certificate programs share the same fundamental courses, and this flexibility permits professionals to easily pursue a different program if their career path changes and evolves. For in-depth information and program requirements for PERI’s certificate programs, please visit our web site at http://peri.org/peri-certificate-programs/

InformationfoundinthiscatalogiscurrentasofFebruary2017.PleasecheckthePERIwebsiteforup-to-dateinformation.

CONTINUING EDUCATION CREDIT

CERTIFICATE PROGRAMS


For more than 25 years, PERI has offered educational opportunities to the pharmaceutical, biological, and medical device industries through its Open Courses. PERI has exceeded a level of excellence through these courses by bringing firsthand knowledge and expertise from industry faculty. This perspective provides a valuable benefit to students and is the trademark of PERI courses and workshops. By attending a PERI Open Course, you will learn from faculty presentations, case studies, small group workshops, and personal interaction with course directors and faculty. The second element to learning is the interaction that occurs with other course participants. Each Open Course offers networking possibilities with faculty and peers throughout the course. Maximize your source of news and information about the industry while enhancing the skills that you’ve already learned and put to use.

Course Descriptions The Open, Corporate Education, and Distance Education sections of this catalog describe the content of courses in each respective program. Individual description pages provide information pertaining to educational objectives, target audience, and key topics for Open Courses, as well as date, location, and registration fees. Please see PERI’s website for the most current agenda, faculty list and Course Manager contact information. Registration Information • You may register by mail, phone, or through our

website at www.peri.org. For mail, please submit the registration form printed in this catalog (see page 30).

• Submit your registration form with full payment to hold your place in a program. Full payment must be received no later than three weeks prior to the course start date.

• You may pay by company check (payable in U.S. dollars to PERI, Inc.) or credit card (VISA, MasterCard, or American Express). We regret we cannot accept personal checks. We will email you a confirmation notice after processing your payment.

• See page 29 for the complete registration policy. • PERI reserves the right to change faculty and

presentation times/schedule to accommodate situations beyond its control.

Registration Discounts (cannot be combined) Early Registration Discount Save up to $200 by

registering early! Look for early registration rates and deadlines listed in this catalog and online.

Government and Academic Discount Employees

from government and academic institutions may deduct $200 from the applicable registration fee for two or three-day courses, or $100 for one-day workshops.

Full-time University Students Check with the PERI

registration office for registration discount details. Group Discounts are available on a sliding scale,

beginning with just two individuals from a single company. Save up to 30% when you take advantage of this volume discount.

See page 29 or visit our website for cancellation policies and procedures. For updates and additional information, visit our website www.peri.org.

OPEN COURSES


Project Management for the Pharmaceutical and Biotechnology Industries Course Dates: March 30 - 31, 2017 Early Bird Deadline: February 13, 2017 Regular Course Rate: $1595 Early Bird Rate: $1395 Course Location: PERI Training Facility, Fairfax, Virginia, 22031 This course addresses project management issues and skills needed to wisely choose and effectively develop new therapies in today’s global climate. Key concepts include managing drug development teams through major decision points during the stage-based drug development process (including organizational options team building), resource and budget planning, as well as R&D portfolio management. Educational Objectives Upon completion of this course, participants should be able to:

· Discuss the drug development process and key decision points · Define how to build more effective project teams · Plan and manage development programs · Apply the principles of financial planning · Identify project risks and develop contingency plans

Who Should Attend

· Project Team or Program Managers · Project Coordinators and Team Leaders · Clinical Research Directors · Pharmacists · Regulatory Affairs and R&D Professionals

Key Topics

· The Pharmaceutical Development Process and Environment

· The Art and Science of Project Management · Organizational Challenges and Opportunities · Financial Overview for Project Managers · Project Planning · Risk Management for Project Managers · Team Communications · Managing Alliance Project Teams

Benefits of Attendance: · Understand the activities

and interdependencies of drug development

· Learn project management concepts and challenges

· Build more effective project teams

· Interact with industry professionals

Open Courses: Face-to-Face Education


Regulation of Marketing & Promotion of Pharmaceuticals Course Dates: April 3 – 4, 2017 Early Bird Deadline: February 17, 2017 Regular Course Rate: $1595 Early Bird Rate: $1395 Course Location: PERI Training Facility, Fairfax, Virginia, 22031 This course presents industry and FDA experts on current issues regarding FDA regulation of promotional activities such as direct-to-consumer advertising, social media, scientific exhibits, off-label communications as well as trends in FDA enforcement. Learn how new developments in product liability and application of Anti-Kickback laws and regulations will affect your ability to market and promote prescription drugs. Walk away with best practices in complying with the Federal Food, Drug & Cosmetic Act, the Anti-Kickback Statute and the new PhRMA Code on Interactions with Healthcare Professionals and how to fashion a message about your product. Educational Objectives Upon completion of this course, participants should be able to:

· Explain the key public policy factors affecting the regulatory environment · Describe legal and regulatory requirements, appropriate professional and industry

guidelines, and current trends in marketing pharmaceutical products · Recognize the views and positions of major players in the regulation of promotional

materials: US Food and Drug Administration, American Medical Association, Inspector General of Health and Human Services, US Congress, and others

Who Should Attend · Marketing, Sales and Business Professionals · Regulatory Affairs Personnel · Project Managers · Pharmacists · Product Label Staff

Key Topics

· FDA Regulation of Promotional Activities · Complying with Food, Drug & Cosmetics Act · PhRMA Code on Interactions with Healthcare

Professionals · Regulation of Product Promotion – There’s More

Than Just the FDA · Product Liability Implications · Direct-to-Consumer (DTC) Advertising · Commercial Support · FDA Guidances on Social Media Promotion

Benefits of Attendance: · Learn best practices in

reviewing promotional material

· Gain guidance on how to represent the advertising department and support marketing, sales, and business departments

· Dialogue directly with regulatory and legal experts on off-label issues


Biologics and Biosimilars: An Integrated Overview of Product Development Course Dates: April 27 - 28, 2017 Early Bird Deadline: March 17, 2017 Regular Course Rate: $1595 Early Bird Rate: $1395 Course Location: PERI Training Facility, Fairfax, Virginia, 22031 This course provides a brief history of biologics and follow-on biologics (also known as biosimilars) and how they are regulated, describes the key aspects of chemistry, manufacturing and controls (CMC) for various types of biologic products, defines principles underlying biologics safety and clinical trial assessments, and aids in developing a planning strategy for toxicology and clinical studies supporting biological drug development. Participants will gain a broad multidisciplinary understanding of the scientific, management and regulatory decision points in the development of new biologics. Educational Objectives Upon completion of this course, participants should be able to:

· Discuss the difference between small molecules and biologics in terms of regulatory pathways to approval

· Describe the differences between biologics and biosimilars · Describe key components of pre-clinical packages required for regulatory approval of

biologics · Describe key pharmacovigilance concepts including safety risks · Discuss the utility of biomarkers in the development of biologics including oncology

products Who Should Attend

· Clinical and Nonclinical Professionals · Manufacturing Personnel · Regulatory Affairs Professionals · Seasoned Small-Molecule Developers

Transitioning into Biologics and Biosimilars Key Topics

· The History of Biologics · The IND/BLA Regulatory Procedure · Biotech Toxicology · Overview of Clinical Trial Design · Immunogenicity · Getting your Biologic into Humans Workshop · Managing the Development Process through

Multidisciplinary Project Teams

Benefits of Attendance: · Learn the history of biologics

and how they are regulated

· Walk away with an understanding of the preclinical studies used to support clinical trials

· Work with peers to develop a strategy for developing new biologics, from FIH to product launch

· Learn from FDA and industry experts about biologics and biosimilars


Basic Drug Development: Overview of Biopharmaceutical Research & Development Formerly “Basic Drug Development: From Molecule to Market” Course Dates: May 18 - 19, 2017 Early Bird Deadline: March 31, 2017 Regular Course Rate: $1595 Early Bird Rate: $1395 Course Location: PERI Training Facility, Fairfax, Virginia, 22031 In a blending of online and live learning, this course provides an overview of the process and issues common to all new chemical entity (NCE) development projects, including small molecule and biologics, from research and development stages through product launch and post-marketing safety. The course focuses on decisions that need to be made throughout the therapeutic development process and criteria influencing these decisions. The online component is PERI’s interactive Decision Points in Pharmaceutical Development. Educational Objectives Upon completion of this course, participants should be able to:

· State the basic steps in the drug development process; · Explain the difference between research and development; · Discuss key decision points in the drug development process; · Explain implications of label-based drug development; · Discuss the role of interaction with FDA and other regulatory agencies.

Who Should Attend

· Professionals new to Drug Development · Scientific and Non-Scientific Staff Members · Members of Clinical Research Teams · Pharmacists · Medical Writers and Communication Specialists · Project Managers and Regulatory Affairs Personnel

Key Topics

· Non-Clinical Drug Development · Decision Points in Drug Development · Regulatory Review Process (FDA, EMA) · Meeting with Regulatory Agencies · Drug & Biologic Product Manufacturing · Clinical Trial Design · Safety in the Drug Development Process · Global Considerations in Drug Development · Panel Discussion with FDA Representatives:

“Putting It All Together”

Benefits of Attendance: · Identify the basic steps in

drug development

· Gain hands-on experience through practical drug development workshops

· Understand team responsibilities in pharmaceutical development

· Learn key aspects and updates in the regulatory process for US, Europe and Japan


Ethical Issues in the Prescription Drug Industry Course Dates: July 17, 2017 Early Bird Deadline: May 26, 2017 Regular Course Rate: $995 Early Bird Rate: $895 Course Location: PERI Training Facility, 9302 Lee Highway, Fairfax, VA 22031 New Seminar for 2017! The modern pharmaceutical industry is undoubtedly responsible for some of the greatest advances in the history of human health care. Yet this very progress presents unique challenges from an ethics standpoint. How do we decide who benefits from the industry’s research and discoveries and who does not? Does the industry deserve its largely negative popular image? This highly interactive course begins with an overview of ethical theory and a review of the history of drug regulation in the United States, including the often tragic events that led to major regulatory reforms. The course then covers ethical considerations that bear on preclinical and clinical research, prescription drug pricing, and promotional activities. Lastly, consideration is be given to Corporate Social Responsibility (CSR) and the notion that the pharmaceutical industry has a supererogatory moral obligation to those in need of its products. Educational Objectives Upon completion of this course, participants should be able to:

· Provide a concise foundation in ethical theory · Discuss some key ethical considerations in experimental drug research · Describe the role of ethics in clinical research · Discuss ethical considerations involved in pricing and promotional activities · Consider the Industry’s putative ‘Good Samaritan’ obligations to society

Who Should Attend

· Pharmaceutical Industry Professionals and Thought Leaders at Any Level · Program Team Leaders and Project Managers · Regulatory Personnel · Clinical/Medical Researchers, Managers and Coordinators · Marketing and Commercial Professionals · Scientific and Non-Scientific Staff

Key Topics

· History of Prescription Drug Regulation in the United States · Ethics & Experimental Research in the Pharmaceutical Industry · Ethics & Clinical Research · Pharmaceutical Pricing & Promotion · Corporate Social Responsibility


Working with Company Core Data Sheets and Core Safety Information Interactive Labeling Webinar Series Individual Sessions: $250.00 Course Time: Wednesdays, 12:00 – 1:30 PM Eastern Time Developed and taught by Dr. med. Leander Fontaine, Pharmiceutics LLC, this series of webinars provides a solid foundation for professionals responsible for designing and maintaining the content of CCDS and CCSI, and for governing global implementation of core labeling. February 8, 2017: The CCDS as a Document This session addresses the essential features and associated business rules, as well as the meaning of Company Core Safety Information (CCSI). February 15, 2017: Populating the Adverse Reactions Section of the CCDS – Part 1 This session describes why definitions of the concept “adverse reaction” for purposes of regulatory reporting are usually not suitable for core or local labeling. February 22, 2017: Populating the Adverse Reactions Section of the CCDS – Part 2 Participants learn the process for identifying adverse reactions from clinical trials even reports and the different approaches illustrating the frequency of adverse reactions in local labeling. March 1, 2017: Contraindications, and Warnings and Precautions in a CCDS Participants learn the rules for elevating information to the Warnings and Precautions section, when to contraindicate, and the evidentiary standard for elevating information in the USPI. March 8, 2017: Other Safety Information in a CCDS This session addresses additional safety information found in the CCDS, including interactions and preclinical safety data, as well as pregnancy, lactation and fertility in a CCDS. March 15, 2017: Other Key Information in a CCDS This session addresses additional information in the CCDS, including indications, dosage and administration, clinical pharmacology, clinical trials, excipients. March 22, 2017: Development Core Data Sheets and Development Core Safety Information This session addresses when labeling activities should begin and compares the CCSI and DCSI.

BLENDED ONLINE PROGRAMS & WEBINARS


Basic Pharmacology Online Blended Course Course Dates: March 28 – April 25, 2017 Series of five webinars, each Wednesday beginning March 28, 2017 Phamacology Online distance education course includes four months of access Course Rate: $995 PERI’s Basic Pharmacology Online Blended Course pairs the fundamental Pharmacology Online distance education program with weekly webinars, case studies and online discussions to enhance learning and retention of key basic research information. This virtual course provides an intensive overview of pharmacology, knowledge of which is critical for both drug discovery and development. The principles of pharmacodynamics and pharmacokinetics are presented, followed by an introduction to the pharmacology of the autonomic nervous system, cardiovascular system and central nervous system. Our foundation program blends online technology platforms with didactic teaching and practical workshops. Weekly webinar sessions incorporate discussion and presentations on key topics in basic pharmacology that align with the five modules of the distance education program. Educational Objectives Upon completion of this course, participants should be able to:

· Describe the general principles of pharmacology; · Interpret the interrelationships between pharmacodynamics and pharmacokinetics; · Discuss the effects of drugs on the sympathetic and parasympathetic elements of the

autonomic nervous system; · Relate pharmacology as it applies to the major organ systems, central nervous system,

and cardiovascular system.

Who Should Attend · Clinical Research Associates · Regulatory Affairs Professionals · Chemistry Staff · Pharmacists · Product & Project Managers


PERI’s Corporate Education Programs are delivered directly to your company at your facility, and can be tailored to your company’s specific educational needs and objectives. For 15 years, PERI has been providing the highest level of on-site education to the pharmaceutical, biotech and medical device industries.

PERI’s Corporate Education clients include more than 350 pharmaceutical, biotechnology and government organizations.

Visit our website at www.peri.org for updates on course offerings.

PERI Corporate Education Programs are… Cost Effective: You can save time and money by

having PERI train a group of 10 or more team members at the location of your choice. Reduce travel expenses, time away from work and more with training on-site or at a nearby location.

Customized Programs Developed By Expert

Faculty: Courses are designed to address the specific needs of your company by expert PERI faculty, many of which have years of industry and educational experience.

Additional Features & Benefits: - PERI’s open courses are

available to corporate education clients for customized group education

- Discounts are available for multiple courses

- Programs can be offered to virtual audiences via webinar/webcast

- Continuing education credits available for Physicians, Pharmacists and others

CORPORATE EDUCATION PROGRAMS


PERI’s Customized Webinar/Webcast and Blended Education Programs In addition to on-site training with PERI staff and faculty, consider adding webinars and webcasts to your curriculum! Customized blended-education programs are available to supplement live learning and enhance the training experience. Combining webinars/webcasts with live learning also helps reduce program expenses. Topics Include: - Overview of Biopharmaceutical Development - Toxicology for Non-Toxicologists - Good Clinical Practices - Postmarketing Safety Reporting - Imaging Approaches to Oncology Drug

Development - Pediatric Investigation Plans (PIP) - Risk Management: EMA Perspective - Biosimilars: Development Considerations and

Current Regulatory Environment - Pharmacoeconomics - Global Pharmacovigilance - Overview of Prescription Drug Labeling

Regulations - And Many More!

Student Testimonials Here’s what PERI participants are saying:

On Cancer 101: “I can now begin to work in oncology with a baseline understanding of the therapeutic area.”

On Clinical Trial Management: “This course helps me to better understand the development and correct documentation for all the agencies that monitor clinical trials.”

On Drug Development: “Love the workshops! Excellent activities and follow-up discussions. I learned that it is not easy to manage a portfolio because of all the elements you must consider.”

On Global Regulatory Affairs: “I can now interact more effectively with regulatory affairs experts in different regions.”

On Good Clinical Practices: “A great refresher for prior GCP courses; gives a broad picture about clinical trials.”

On Project Management: “Honestly, the best and most useful of all the courses I have taken with PERI!! I found some things to try on my research-phase project, i.e., how to approach timelines and how to address the pushback on the ‘you can’t predict science’ mindset.”

On Regulation of Marketing: “I am better able to medically review promotional pieces with an understanding of FDA and OPDP’s perspectives.”


Fundamental Training Programs Biologics Product Development provides an overview of the processes and problems common in the development of biologics. Participants will understand development decision points from initial identification to post-approval monitoring.

Decisions in Drug Development: Portfolio Management Workshop is a highly interactive, hands-on learning experience! This 4-hour workshop provides an overview of the processes and challenges common to all new development products, basic drug development steps and ideal characteristics of a development candidate. Interactive workshops will then follow the development of a drug from discovery to product label development.

Drug Development Decisions: The NDA Simulation Workshop provides a better understanding of the drug development and regulatory processes by simulating a "company project team" working together to get their "drug" approved with the required label and within projected timeline and budget. The initial portion of the course provides didactic presentations, which provide the groundwork for the IND and NDA Game simulations.

Medical Devices: Demystifying Regulation and Guidance provides an overview of safety considerations of medical devices. This course identifies critical definitions, classifications and device categories.

Pharmacology Concepts provides an intensive overview of pharmacology, including the principles of pharmacodynamics and pharmacokinetics. A general introduction to selected therapeutic areas is also included, and can be tailored to your company’s area of specialty. Specific courses are also available on Pharmacokinetic Concepts and Applying Pharmacokinetics and Pharmacodynamics.

Oncology Cancer: Introduction to Oncologic Product Development is designed to cover oncologic clinical trial design from Phase I through Phase III. In addition, the course provides an overview of human cancer pathophysiology and current therapeutic issues relevant to the client’s specific development areas. Also available is Cancer 101: A Basic Overview of Oncology Drug Development, which provides a foundation for new oncology researchers.

SPOTLIGHT COURSE: Build a foundation for your entire team!

Basic Drug Development: Overview of Biopharmaceutical R&D provides an in-depth overview of the processes and challenges common to all product development projects. Interactive workshops follow the development of a drug and/or biologic from discovery and research to product label development.

Catalog of Corporate Programs


Oncology Development: Overview for Market Planning provides an introduction to the cancer disease process and an overview of treatment method categories for the purposes of market planning. Also discussed are an overview of oncology clinical trial design and the approval process of oncology drugs. Specific cancer therapeutic areas can be tailored to client’s needs.

Quality Assurance and Compliance Clinical Monitoring: Essential Concepts presents an overview of clinical monitoring in context of the overall drug development process, FDA regulations and International Conference on Harmonization (ICH) guidelines for Good Clinical Practices.

Global Pharmacovigilance focuses on introductory concepts of global regulatory requirements in drug safety. Topics include MedDRA, basic epidemiological issues, signal detection and risk management.

Good Laboratory Practices addresses regulatory compliance principles relative to the FDA’s current Good Laboratory Practices (GLP) regulations. Topics include: Development of GLPs, roles and responsibilities of key staff members, SOPs, laboratory facilities, and computer validation issues. Regulatory Inspections: Preparation and Practice describes the necessary steps in preparing for a Regulatory Site Inspection. Key topics include current inspection issues, differences in inspections from global agencies, handling inspections and preparing for inspections. A mock “Site Audit” can be conducted as a practical exercise, followed by a debriefing of the inspection findings. Also available to audiences of varying experiences: Preparing for an Advisory Committee Meeting.

Project Management and Leadership Development Project Management and Leadership Strategies for Pharmaceutical Scientists focuses on improving the leadership skills of project leaders and mid-level line managers who work in an environment that requires collaboration in order to be successful. The program uses an analytical model of leadership that is readily accepted by technically oriented people.

SPOTLIGHT COURSE: Inhibitors, Imaging, and Immunotherapy

Intermediate and Advanced Concepts in Oncologic Product Development is designed to cover oncologic clinical trial design considerations and regulatory issues. Topics include: Clinical trial management operational issues, chemoprevention, angiogenesis inhibitors, new imaging approaches, and cancer pathophysiologies.


Clinical Research & Development Asthma and COPD: Clinical Drug Development provides a comprehensive overview of asthma and COPD as a basis for developing new drugs to more effectively treat these diseases. Pulmonary physiology, pulmonary physiology testing, current treatment approaches, and a review of regulatory policies in this area will be used to discuss recent approaches to developing new drugs for asthma and COPD. Clinical Trial Management and GCP Essentials provides a foundation of GCP concepts, followed by a focus on auditing techniques and strategies, clinical trial management issues and skills needed to effectively conduct trials in the fast-paced drug development industry.

Cardiovascular Product Development provides an overview of advances in cardiovascular drug development. Topics include anatomy and physiology associated with hypertension, coronary disease, heart attack, and heart failure, Coronary and peripheral artery disease, thrombosis, and anticoagulation, cardiac arrhythmia and clinical trial methodology are discussed. Topics on cardiac-related medical devices can also be included.

Clinical Investigator Training instructs practicing physicians on the basics of planning and implementing clinical research trials. Topics can be tailored to provide information on specific disease states, protocols and other company-specific details.

Clinical Trial Management and Operations addresses trial management issues and skills needed to effectively conduct trials in the fast-paced drug development industry. The course presents a variety of topics on trial planning, operational aspects, organizational tips, resource planning ideas, financial implications, timeline concerns, regulatory implications, communication, and team building. Good Clinical Practices and Advanced GCP provides a background in Good Clinical Practices (GCP) as applied to clinical trials conducted worldwide. The Advanced course focuses on GCP auditing techniques and strategies, providing in-depth application-oriented experiences.

Regulatory Affairs Global Regulatory Affairs provides participants with an overview of laws, guidelines and regulations governing the development and registration of prescription pharmaceuticals outside United States. Regions specific to our client’s needs are covered.

SPOTLIGHT COURSE: Explore New Regulations and Guidances

Regulation of Marketing and Promotion of Pharmaceuticals addresses current laws, guidelines and regulations governing the marketing and promotion of prescription drugs and biologic agents. For a broader perspective, an overview course on Prescription Drug Labeling Regulations is also offered.


Additional Courses Available … Or Customize Your Own!

· Clinical Data Management · CMC in the CTD · Conducting Phase I Trials · Diabetes: Epidemiology and Pathologies · Effective Negotiations in BioPharma · Filing IND, NDA, BLA · Immunology · Managing Investigator Initiated Research · Managing Outsourcing to CROs · Metabolic Syndrome · Oncology Development: Regulatory Considerations · Pharmacology: Advanced Concepts · Preparing for an Advisory Committee Meeting · Product Launch · Protocol Writing · SOP Development · US Regulatory Overview · Vaccine Development

ESSENTIAL ONLINE LEARNING: Build a foundation for your entire team!

Decision Points in Pharmaceutical Development focuses on the critical decisions made during a question-based label-driven approach to development of a pharmaceutical candidate from discovery through product launch and marketing. The online course highlights decisions involved in the identification of a lead pharmaceutical candidate, conducting preclinical work to provide safety data to support initial human clinical studies, establishing optimal therapeutic doses with an acceptable benefit-to-risk ratio, generating a label, and deciding to file an NDA or BLA. We can customize course content, length, and format to suit the needs of your team. The course is structured with lectures and workshops, creating an interactive, engaging learning experience. Corporate licensing is available for the distance education web-based module, which underwent a major overhaul in 2016. Learners who participate in this introductory online self-study course should expect to spend about six hours to complete the program, which features revised information and new content! This option offers participants the ability to participate and complete the program on their own schedule and at their own pace. An Interactive live webinar can be recorded and/or streamed to employees around the world, allowing your team members to receive the same training - regardless of location. Customize the program to focus on select topics or review the drug development process from a particular point of view. Webinars are available as 3 or 4-hour sessions. Drug Development for Non-Scientists has been especially designed to enable personnel without a scientific background to understand the drug development process. The course is fully flexible and is offered online, as well as an in-person as a one-day or two-day program.


Have restrictions on travel? Can’t get away from home or office? Have a limited training budget? Need training right now?

PERI brings the classroom to you! What You Can Expect PERI’s distance education courses have been designed as self-study learning activities that are delivered completely over the Internet. Courses include the following features and tools: · Comprehensive course content written by expert faculty from industry, FDA, academia · Bookmark function to hold your place in the course · Online reference links · Common industry abbreviations and acronyms · Glossary of terms

· Exercises and case questions · Self-assessment quizzes

Benefits of Web-Based Courses · Save Time - Save time you might otherwise have spent traveling. · Save Money - Eliminate travel costs and take advantage of lower registration fees. · Convenience - Take a class when you need it, not when it happens to be offered. · Flexibility - Learn at a place and pace that best suit you and your schedule. · Validation - Demonstrate knowledge gained through self-assessments.

Corporate Licensing of Distance Education: Packages for distance education courses are available for companies to train groups of 10 or more individuals. Corporate licensing offers numerous benefits, including: • Significantly reduced per-student registration fees • Access to reports on student progress • Easy training of global staff • Pre-payment options • Data sharing with Learning Management Systems Registration Discounts/Cancellation Policies After submitting registration, you will receive email notification of course access as soon as payment is confirmed. Registrations will not be processed without full payment.

Academic/Government Discount: Employees from government and academic institutions are eligible for a $100 discount on web-based courses. Full-time college/university students should check with PERI registration staff for discount details.

Group Discounts are available on a sliding scale when you register at least five (5) individuals for distance education courses. Save up to 20% when you take advantage of this volume discount. Cancellation: All cancellation or replacement requests must be made in writing, via fax 571-490-8408, Attention: Registrar/Distance Education; or emailed to [email protected]. No requests made via telephone will be honored. You may cancel your registration or transfer your registration to a co-worker if you have NOT accessed the course. Refunds for cancellations will be issued LESS a $100 enrollment fee. Cancellations and transfers will not be issued once a course has been accessed. Extensions: If you are unable to complete the distance education course in the time allotted, you may request an extension. Requests for an extension must be made in writing, and there will be a fee of $100 for each addition of 30 days of extended access.

DISTANCE EDUCATION


Applied Good Clinical Practices (GCP) Course Rate: $590 Access Length: Four (4) Months Course Length: ~15 hours of study time to complete this course This course will provide you with a background in Good Clinical Practices (GCPs) as applied to clinical trials currently conducted worldwide. The curriculum will emphasize GCP requirements and quality assurance functions for clinical trials from several perspectives, including those of the sponsor-monitor and the quality assurance group, institutional review boards (IRB)/ethics committees (EC), and the clinical investigators. GCPs will be discussed from the regulatory perspectives of FDA and ICH. Educational Objectives Upon completion of this course, participants should be able to:

· Interpret FDA regulations and International Conference on Harmonization (ICH) guidelines pertaining to GCPs;

· Identify regulatory, source documentation, and recordkeeping requirements for clinical trials;

· Describe components of internal auditing systems; · Explain roles and responsibilities of sponsor, monitor, investigator, and regulatory

authorities in ensuring proper conduct of clinical trials; · Apply GCP principles to the collection and reporting of adverse events.

Who Should Attend

· Quality Assurance Associates · Regulatory compliance professionals · Clinical Research Associates · Medical Monitors · Pharmacists

Key Topics

· Institutional Review Board (IRB)/Ethics Committee Responsibilities · Regulatory Environment in the US · International GCP Regulations · Investigator Responsibilities · Sponsor Responsibilities · The Protocol · Sponsor Obligations

· Monitoring Responsibilities · Clinical Quality Assurance (CQA)

Group · FDA Inspections · Managing FDA Inspections

Online Self-Study Distance Education Courses


Decision Points in Drug Development: Discovery to Launch Course Rate: $450 Access Length: Two (2) Months Course Length: ~6 hours of study time to complete this course This introductory course focuses on critical decisions made during a question-based label-driven approach to development of a pharmaceutical candidate from discovery through to product launch and marketing. The course highlights decisions involved in the identification of a lead pharmaceutical candidate, conducting preclinical work to provide safety data to support initial human clinical studies, establishing optimal therapeutic doses with an acceptable benefit-to-risk ratio, generating a label, and deciding to file an NDA or BLA. A key element of the module is discussing how the development of a pharmaceutical candidate is a stepwise approach for learning, confirming and affirming that together with the product label drives the pharmaceutical development process. Educational Objectives Upon completion of this course, participants should be able to:

· Understand the pharmaceutical development process; · Describe each knowledge-based phase of the pharmaceutical development process; · Understand the importance of, and differences between, Learning Studies and

Confirming Studies; · Define critical decision points in the pharmaceutical development process; · Utilize questions and critical decision points to design a pharmaceutical

development plan. Who Should Attend

· Individuals from any discipline new to drug development. Key Topics

· History of Drug Regulation: Who Regulates and Why Contemporary, Knowledge-Based Drug Development as Compared to the Traditional, Activity-Based Approach

· Critical Drug Development and Review Decision Points · Successful and Failed Drug Development Programs


The Regulatory Context for Conducting Clinical Trials Course Rate: $240 Access Length: Two (2) Months Course Length: ~3 hours of study time to complete course This course is designed to interpret FDA regulations and ICH guidelines to apply to informed consent, adverse event and drug accountability reporting, ethical conduct during clinical research and to define the IRB/EC's. Participating in this course will prepare the learner to efficiently conduct safe clinical trials that are in compliance with GCP regulations and guidelines. Educational Objectives Upon completion of this course, participants should be able to:

· Interpret FDA regulations and ICH guidelines pertaining to GCPs; · Apply GCP regulations and guidelines to your processes around informed consent, adverse event reporting, records and reports, and drug accountability; · Describe the IRB/EC responsibilities for ensuring the ethical conduct of

clinical research. Who Should Attend

· Study Site Investigators · Site Monitors and Auditors · Research Nurses · Regulatory Affairs Associates · Data Management personnel

Key Topics

· Regulatory Environment in the United States · International GCP Regulations · Institutional Review Boards/Ethics Committees

This is the first course in the Good Clinical Practices for the Clinical Research Team Series. Series Description This course provides a review of the clinical trial process. This course is different from many other courses in that its perspective is from that of the site-based investigator rather than the sponsor. This course provides an excellent tool for training and educating all members of the sponsor and clinical research teams to ensure knowledge and understanding of the clinical research process and GCPs. Save when you bundle programs in series - all 3 courses for only $590!


Implementing a Clinical Trial Program Course Rate: $320 Access Length: Two (2) Months Course Length: ~4 hours of study time to complete course This course addresses clinical trial management issues and skills needed to effectively conduct clinical trials. Key course factors include investigator selection and responsibilities, clinical research protocol, data management, and adverse event reporting. Participating in this course will prepare the learner to efficiently conduct safe clinical trials that are in compliance with GCP regulations and guidelines. Educational Objectives Upon completion of this course, participants should be able to:

· Identify sponsor responsibilities in a clinical trial; · Discuss key considerations when selecting a Principal Investigator; · Describe key elements for protocol development; · Discuss issues central to data management in a clinical trial; · Identify actions that must be taken when an adverse event is reported; · Explain the FDA inspection process and identify areas of common deficiencies.

Who Should Attend


Key Topics

· Sponsor Obligations · Protocol Development and Content · Data Management · Adverse Event Reporting · Investigator Responsibilities

This is the second course in the Good Clinical Practices for the Clinical Research Team Series. Series Description This course provides a review of the clinical trial process. This course is different from many other courses in that its perspective is from that of the site-based investigator rather than the sponsor. This course provides an excellent tool for training and educating all members of the sponsor and clinical research teams to ensure knowledge and understanding of the clinical research process and GCPs. Save when you bundle programs in series - all 3 courses for only $590!


Ensuring Subject Protection & Scientific Integrity Course Rate: $160 Access Length: Two (2) Months Course Length: ~2 hours of study time to complete course This course explains the FDA inspection process, identifies common deficiencies and regulations guiding FDA inspections and identifies the sponsor’s responsibilities in monitoring study sites. Participating in this course will prepare the learner to efficiently conduct safe clinical trials that are in compliance with GCP regulations and guidelines. Educational Objectives Upon completion of this course, participants should be able to:

· Identify the Sponsor's responsibilities for monitoring study sites; · Explain the FDA inspection process and identify areas of common deficiencies.

Who Should Attend


Key Topics

· Monitoring of Clinical Studies · Clinical Quality Assurance (CQA) · FDA Inspections

This is the third course in the Good Clinical Practices for the Clinical Research Team Series. Series Description This course provides a review of the clinical trial process. This course is different from many other courses in that its perspective is from that of the site-based investigator rather than the sponsor. This course provides an excellent tool for training and educating all members of the sponsor and clinical research teams to ensure knowledge and understanding of the clinical research process and GCPs. Save when you bundle programs in series - all 3 courses for only $590!


Pharmacology Online Course Rate: $615 Access Length: Four (4) Months Course Length: ~15 hours of study time to complete this course This course provides an intensive overview of pharmacology, knowledge of which is critical for both drug discovery and development. The principles of pharmacodynamics and pharmacokinetics are presented, followed by an introduction to pharmacology of the autonomic nervous system, cardiovascular system, and central nervous system. Inflammation and anti-inflammatory drugs are presented next, and the course concludes with a discussion of agents used in infectious disease and chemotherapy. Educational Objectives Upon completion of this course, participants should be able to:

· Describe the general principles of pharmacology; · Interpret interrelationships between pharmacodynamics and pharmacokinetics; · Discuss effects of drugs on the sympathetic and parasympathetic elements of the

autonomic nervous system; · Relate pharmacology as it applies to the major organ systems, central nervous system,

and cardiovascular system. Who Should Attend

· Project Managers · Clinical Research Associates · Medical Writers · Regulatory Affairs specialists · Marketing professionals

Key Topics

· Principles of Pharmacodynamics · Introductory Pharmacokinetics · System Review I: Autonomic Nervous System Pharmacology · System Review II: Cardiovascular System Pharmacology · System Review III: Central Nervous System Pharmacology


Statistical Concepts Used in Clinical Trials Course Rate: $645 Access Length: Four (4) Months Course Length: ~12 hours of study time to complete this course This course reviews statistical terminology, provides an understanding of statistics, and explains trial design from a clinician's viewpoint. Most importantly, the course illustrates how statistical tests are chosen and interpreted. The course is designed to allow you to think like a statistician, but it is not designed to teach you to be a statistician. The course emphasizes the importance of an ongoing collaboration with a statistician. It is this collaboration that creates synergy, enhances creativity, and improves trial design, execution, and analysis. Educational Objectives Upon completion of this course, participants should be able to:

· Identify patient populations and calculate the appropriate sample size for clinical trials; · Choose the trial endpoint and treatment difference to be detected; · Select statistical tests; · Interpret P-Values and determine statistical significance; · Determine the probability of detecting the drug effect.

Who Should Attend

· Physicians · Clinical Research Administrators · Clinical Trial Associates

Key Topics

· Introduction to Statistical Concepts in Trial Design · Patient Population · Control Treatment · Is the Experimental Treatment Better? · P-Values and Statistical Significance · Calculating the Sample Size of a Trial · Choice of a Statistical Test


On-Demand Sessions on Featured Topics in Biopharmaceutical Development Did you ever have a meeting scheduled in the middle of a session in a webinar series? Had to stay home from work when an interesting webinar was held? Archived copies of several PERI webinars are available for purchase. These 60 to 75-minute sessions can be accessed on-demand whenever you need a refresher, an overview to a new topic, or clarification on specific diseases or regulations. Webinars available in following fields:

· Basic Research Courses · Emerging Topics in Drug Development · Global Clinical Trials · Labeling · Oncology · Product Development & Launch · Pulmonary Drug Development Preview sessions online first!

Explore immuno-oncology with this in-depth series! Individual Sessions: $175.00 Bundled Series Price: $800.00 Special Introductory Series Price (through March 1, 2017): $600.00 This series of six webinars covers the area of immune-oncology in the context of pharmacologic and immunologic background, specific agents now approved, and changing practices and outlook for the cancer patient The field of immune-oncology has exploded in the past five years, and has achieved transformational successes in a number of important human malignancies. Professionals in the field, as well as primary caregivers, pharmaceutical researchers, third-party payers, commercial decision-makers, and patient advocates, need comprehensive understanding of this area as it relates to their roles. Session 1 – Pregame Ceremonies: Cancer Biology, Oncology and Immunology Session 2 – The Home-Field Advantage: Tumor Immunology Session 3 – The Starters: Monoclonal Antibodies Session 4 – The Deep Bench: Cytokines and Vaccines Session 5 – The Bull Pen: Targeted Small Molecules Session 6 – The New Rule Book: Pharmacodynamics and Pharmacokinetics

of Biologicals

TREATING CANCER: A WHOLE NEW BALLGAME

ARCHIVED WEBINARS


· Registrations will not be processed without full payment. · You may register by mail, phone, fax, email, or through

PERI’s secure website. · Submit your registration form with full payment in order

to hold your place in a program. Registration fees are listed on the individual course pages of the website.

· We accept Visa, MasterCard, and American Express. You may also pay by bank or company check. We regret we cannot accept personal checks. To pay by check, please make checks in US dollars payable to PERI, Inc.

· If paying by check, PERI will hold your registration form until a check is received. Payment must be received at least three weeks prior to the start of the course in order for your registration to be processed. Check requests will not be accepted within three weeks of the course start date.

· Substitution: PERI will accept a registration substitution at any time prior to the start of the program. Please fax your substitution request to 571-490-8408.

· No-Shows: Registrants who are enrolled in a course and do not attend the program (“no-show,”) will not receive a refund.

· Program Discounts: Course discounts are available for employees from government and academic institutions, full-time college students, and groups from the same company. Corporate licensing is available for web-based courses. Contact the PERI office for details.

· Waiting List: Registrants on a waiting list who cancel or do not get into a course are not subject to cancellation fees.

OPEN ENROLLMENT COURSES · Cancellations: Refund requests will be honored, less a

cancellation fee, if written notice is received by PERI according to the following schedule: 30 days or more prior to first day of course – cancellation fee is 10% of registration fee; 29 to 10 days prior to first day of course – cancellation fee is 25% of registration fee; 9 days or less prior to first day of course – cancellation fee is 100% of registration fee.

· Cancellations: If PERI must cancel a course due to weather conditions or for any other reason, PERI will issue a full refund of the registration fees paid. In the event PERI cancels a course, PERI will refund the cancel/change fee for entire airline ticket but will not process refunds for hotel rooms.

· Transfers: Transferring to another course may be done if written notice is received by PERI at least 10 days prior to the start of the program. Transfers will not be honored after this date. If the fee for the replacement course is more than what is available to transfer, you will be responsible for paying the difference and your registration will not be confirmed until we receive payment. The balance is due within 30 days from the transfer date or the beginning date of the replacement course, whichever is earlier, or your registration will be forfeited. Transfers will be honored for one year from the date of the original course. After one year, your registration fee will be forfeited.

· Hotel Reservations: Participants are responsible for making hotel reservations. Participants are advised to make refundable or cancelable hotel reservations; PERI will not reimburse for non-refundable hotel reservations in the event of a course cancellation or reschedule.

LIVE WEBINARS · Cancellation: Refunds will be honored (less a $50

processing fee) if written notice is received by PERI at least five business days prior to the start of the program. Refunds will not be honored after this date.

· If PERI must cancel a course due to technical difficulties, weather conditions or for any other reason, PERI will issue a full refund of registration fees paid.

DISTANCE EDUCATION COURSES · Cancellation: Refunds will be honored (less a $100

enrollment fee) if written notice is received by PERI before accessing the course. Once you have accessed the course for any amount of time, cancellations and transfers will not be issued.

· Extensions: If you are not able to complete the distance education course in the time allotted, you may request an extension. Requests for an extension must be made in writing, and there will be a fee of $100 for each additional 30 days of extended access.

BLENDED EDUCATION COURSES · Definition: PERI offers some courses in a blended

format, that is, the course may contain live and distance learning components (online courses and/or webinars). The course fee covers both the open enrollment and distance learning components for a single registrant; students cannot elect to register for only one component of the course. Registration cannot be split between students.

· Terms and Conditions: Upon registering for a blended course, the student will be given information on how to access the distance education component of the course. Students will have the specific access period for each course to complete the distance education component. This time period begins when a student registers for a blended course. Students may request an extension in writing no later than 30 days after the last day of the open enrollment course, and a fee of $100 will be charged for each 30 days of extended access.

· Cancellation: All cancellation and transfer request must be in writing, via fax 571-490-8408, Attention: Registrar, or via email to [email protected]. Substitution or transfer to another course is allowed if no component of the blended education course has been accessed. If the on-line course or webinar has been accessed by the student for ANY length of time, the price of the distance education component as a stand-alone course will be assessed. A fee based on the open enrollment cancellation schedule will be charged on the remaining registration balance. If the distance education course is not completed within 30 days, the last day of the open enrollment component, no refund for any portion of the on-line course or webinar will be provided unless an extension is requested and the extension fee paid.

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PERI, Inc. ● Fax: 571.490.8409 ● Website: www.peri.org ● Email: [email protected]

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PERI, Inc. 9302 Lee Highway Suite 700 Fairfax, Virginia 22031 Fax: 571-490-8408

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