cmc biopharma masterclass · cmc biopharma masterclass uly, nline aerla [email protected] +36 1...

www.glceurope.com

13-14 February, 2020 Novotel Budapest Danube Budapest, Hungary

CMC Biopharma MasterClass

• Take a closer look on the new Biological entities and Biosimilars

• Experience the development of biotherapeutics from Discovery to

Market approval

• Understand the Strains and Cell line development

• Have a chance to meet the Requirements and technical approach for

Phase I, Phase II, Phase III clinical trials

• Learn about the Control strategy life cycle

• Understand the ICH guidelines and Regulatory pathways for New

Biological entities and Biosimilars in EU and USA

HOW YOU WILL BENEFIT:

www.glceurope.com

27-28 July, 2020 Online MasterClass

• Take a closer look on the new Biological entities and Biosimilars

• Experience the development of biotherapeutics from Discovery to

Market approval

• Understand the Strains and Cell line development

• Have a chance to meet the Requirements and technical approach for

Phase I, Phase II, Phase III clinical trials

• Learn about the Control strategy life cycle

• Understand the ICH guidelines and Regulatory pathways for New


HOW YOU WILL BENEFIT:

Andreu Soldevila


Join the training to get a detailed instruc�on on Chemistry, Manufacturing and Controls (CMC) requirements and review processes for clinical trial, registra�on and post approval drug applica�ons


[email protected] +36 1 848 0515www.glceurope.com

27-28 July, 2020Online MasterClass

INTRoDUCTIoN

By THE END of THE MASTERCLASS, THE PARTICIPANTS wILL UNDERSTAND:

wHo SHoULD ATTEND?

This MasterClass will provide a deep and detailed instruction on Chemistry, Manufacturing

and Controls (CMC) requirements and review processes for clinical trial, registration and

postapproval drug applications. Attendees will also have a solid but comprehensive overview

of all relevant regulatory, technical and quality elements, implementation and documentation

of the required CMC analytical and stability knowledge for biotechnology products, including

biosimilar products. Practical examples will be provided as illustration and proper time will be

allowed for discussion designs and outcomes.

• Process development strategies

• Analytical and Formulation development

• GMP manufacture

• Process analytical Technology

• Guidelines and Regulatory pathways for New Biological entities and Biosimilars

• QC release and stability analysts• Stability program managers• Product scientists and test method technical experts (R&D and QC)• Process analytical chemists and process development scientists• Quality assurance specialists• GMP compliance auditors• RegulatoryaffairsCMCauthorsorreviewers• Analytical and stability laboratory managers (R&D through GMP)• Project managers with CMC responsibilities• Business managers with CMC responsibilities• Keystafffrombiotechacademicincubatorsandsmallstart-ups• Contract testing labs• Chemistry, Manufacturing & Controls (CMC) regulatory• biopharmaceuticals, biosimilars or other biologics• Executive and operational managers of pharmaceutical companies, packaging operations• Engineeringstaff• Quality• Product Development Materials handling/management• Product Information Operations• Licensing• Biotech companies HTAs• Governments• Engineering Lean production• Procurement• Purchase/Facilities Manufacturing Technology• Supply chain and logistics• Payers

https://glceurope.com/




Trainer:

Andreu Soldevila,CEO, Leanbio

Dr Andreu Soldevila is the founder and CEo of Leanbio and Co-founder and CEo of Syna

therapeutics, companies dedicated to Biotherapeutics development, manufacture and

commercialization. Leanbio is a CDMo founded in 2014 dedicated to both New Biologic entities

and Biosimilars, whereas Syna Therapeutics is a Biotherapeutics Developer, founded in 2017 and

currently has two products in the pipeline.

AndreuDevelopedasaprofessionalinthefieldofBiotechnologyforthelast20years,moving

from initial applied research to CMC regulatory activities, holding Bioanalysis Head of department

at a multinantional company, Head of R&D in a CMo and current CEo positions.

Dr. Soldevila was responsible for a variety of technological achievements related to new microbial

and mammalian expression Systems and platform for multiplex absolute quantitation of proteins

by LC-MS/MS bottom up approach at picomolar levels with proven capacity to be applied at

discovery, development and manufacture of recombinant proteins and for (non)-clinical trials.

In the last 10 years participated in numerous biotherapeutics projects, including 6 Biosimilar

products, one of them already submitted for Market authorization license.


CMC Biopharma MasterClass 27-28 July, 2020Online MasterClass


daY1 daY2

Break10:10

Break10:30

Break11:50

Break11:30

Break15:10 Break15:10

Break16:30

Break16:30

Lunch13:00

Lunch13:00

END End of day 117:00

END End of day 217:00

09:00

10:20

11:40

14:00

15:20

16:40

16:40

09:00

10:40

12:00

14:00

15:20

09:00

Introduction to Biologics • New Biological entities and Biosimilar

Guidelines and Regulatory landscape • ICH guidelines and Regulatory pathways for New


Life cycle of Biotherapeutics development from Discovery to Market approval • POC • Non clinical trials• Clinical trials • Market approval

Process development strategies • Strains and Cell line development • Upstream development• Downstream development• Quality by design

Analytical and Formulation development• Analytical method development • Formulation development • SetupvsQualificationvsValidation

Summary

Closing

Recap from Day 1

Control strategy life cycle • Raw materials• In process controls • Process analytical Technology• Quality control

Case study I: New biological entity – Part I.

Case study I: New biological entity – Part II.

Case study II: Biosimilar

GMP manufacture • Requirements and technical approach for Phase I,

Phase II, Phase III clinical trials • ProcessValidation

All dates and times are expressed in UTC/GMT+2 on the Agenda.




about GLC

Global Leading Conferences (GLC) is an industry leader in the field of business intelligence. We provide interactive & impactful business platforms and networking opportunities for senior level executives by bringing them together for B2B Conferences, Global Summits, Training & Workshops. Being customer focused and having our client’s priorities at the forefront, are amongst our core values and is of high importance to the way we operate our business.Our passion for customer satisfaction and results, drive us to work with industry experts closely - who fully understand their peers interests and day-to-day challenges - in order to deliver the most impactful events. We are specialized in industries such as; Pharmaceutical, Banking & Finance, Energy, Oil & Gas, IT & Communication, Sales & Marketing, Law and Human Resources.Our commitment is to deliver the latest information to our clients, while maintaining highest quality and standards. By attending GLC events your company will be able to apply advanced strategies to your operations, gain the latest know-how’s and benchmark yourself higher against the competition while enjoying a 5 star environment.

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cmc biopharma masterclass · cmc biopharma masterclass uly, nline aerla [email protected] +36 1...

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