quality across europe 2013 - sarqa.com€¦ · the european qa conference programme committee...

QUALITY ACROSS EUROPE2013

1st EUROPEAN QA CONFERENCE25-27 SEPTEMBER 2013

INVITATION TO BONN

The aim is to have a full European QA Conference involving European regulatory authorities and European QA Societies. The conference will consist of plenary, parallel and workshop/interactive sessions together with a large exhibition and poster area.

There is currently no major European QA Conference, so this is an excellent opportunity for all European QA Societies to promote and share experiences, consider regulatory and guidance updates, to exchange information and hear from European regulators.

The Conference Programme will cover the following GxP areas both in general presentations and for some areas, their own individual streams:

• Good Clinical Practice

• Good Laboratory Practice

• Good Manufacturing Practice

• Good Pharmacovigilance Practice

• Information Technology

• Medical Devices

• Non Regulated Scientific Research

• Animal Health

Nearly all of the presentations will be delivered in English, but translation services will be available from English to German and French and from German to English and French.

For additional information and registration forms visit the European QA Conference website at www.european-qa-conference.com

There are also a number of advertising and sponsorship opportunities available together with full exhibitor packages.

Pre-Conference TrainingWe will also run some pre-conference training on Tuesday 24th September 2013. Details of this training can also be found on the website at www.european-qa-conference.com

The European QA Conference will be held every three years, with the next one being held in the spring of 2016.

The European QA Conference Programme Committee invites you to the first European QA Conference, to be held in Bonn, Germany during the 25-27 September 2013.

www.european-qa-conference.com



The Maritim Hotel is located centrally between Bonn and Bad Godesberg, in the heart of the bustling business centre. The nearby recreation area of the ‘Rheinau’ is just a stone’s throw away along the walking and jogging tracks.

The hotel has 410 elegant spacious rooms all with modern amenities and air conditioning, together with 16 conference rooms and subterranean car parking for 350 cars.

For the energetic there is a swimming pool, sauna, steam bath and fitness centre. There is also a Wellness Studio (Wellness beauty and nails).

THE MARITIM HOTELThe hotel boasts four restaurants and a piano bar.

The Maritim Hotel was the first hotel in Germany to receive the Sustainability Award by ‘Green Globe’ and the European Association of Event Centres (EVVC) in July 2010. The hotel is also a member of the project ‘Sustainable Bonn’ and is constantly evaluating its environmental performance.

For more information on the hotel please visit www.maritim.co.uk/en/hotels/germany/hotel-bonn

8.00 Conference registration

9.00 Opening address DGGF – Steffen Koenig; SOFAQ – Laurent Bouillot; RQA – Louise Handy

SESSION 1 KEYNOTE SPEAKERChairs: Steffen Koenig, Laurent Bouillot and Louise Handy

9.15 Risk Management – Lessons learnt from aviation Manfred Müller, Lufthansa (see main panel opposite for presentation details)

10.15 Break

SESSION 2Chair: Steffen Koenig, IST

10.45 Changes in European Regulation Fergus Sweeney, European Medicines Agency (EMA)

• Changes in European regulation – What can we expect?

• Role of EMA inspections

• Harmonisation

• Update on European regulatory situation – news, recurrent findings, etc.

11.45 Risk-based quality management of clinical trials – What is special about the concept? Gabriele Schwarz, BfARM

• Why do we need a mindset change?

• How should the new approach look?

• Current stage of relevant EMA Reflection Paper

12.45 Lunch

KEYNOTE SPEAKER

Career history

• 1979-1981 Education at the Luftansa Flight Training School in Bremen and Phoenix, Arizona

• First Officer on Boeing 737, Boeing 747/400 and Airbus A340

• 1991 Accident Investigator Training at USC (University of Southern California, Los Angeles)

• 1994 Captains Upgrade

• 1998-2005 Training Captain on B737

• Since 2007 Training and Check Captain A330/340

Additional functions

• 1990-1995 Flight Safety Officer

• 1995-2002 Deputy Safety Pilot

• 2002-2010 General Manager Flight Safety

• Since 2011 General Manager Flight Safety Research

Topics covered in his present role include – Research project (financed by the German Government and Lufthansa) Evidence based risk management, creating safety performance indicators.

Manfred Müller has also presented at many risk management seminars and workshops for various industries such as medicine, mining, chemical industries, public transport and banking.

Manfred Müller will present on risk management – Optimum Team Interaction – a keystone when dealing with HITEC.

The large share of human errors causing accidents in aviation suggested the – at first sight brilliant – solution to replace the fallible human being by an ‘infallible’ digitally operating computer. However, we learned that complex tasks involving quick and difficult decisions cannot be controlled entirely by machines. We need optimum human performance.

WEDNESDAY 25th SEPTEMBER 2013

Since a single person is always ‘highly error-prone’, the principle solution of the problem is optimum team interaction. The probability that two persons make exactly the same mistake at the same point within an operating process is relatively low, as long as the two ‘thought machines’ collect and evaluate the available facts independently from each other before discussing and clarifying the further steps. The independent work of mind results in a safety network that is able to cushion human errors.

A comprehensive survey showed the following result: Far and away the most frequent safety-critical situation (37.8% of all events) consists of the following combination of risk factors:

1. A complication develops.

2. In this situation of increased stress a human error occurs.

3. The negative effects of the error cannot be corrected or eased because there are deficiencies in team interaction.

It needs to be pointed out that a negative social climate is not identical with a dispute: Too much or too little respect, contempt, misunderstandings, not expressing unclear concern, can reduce the efficiency of a team considerably.

It is almost a paradox of human history: Man’s efforts to develop machines that compensate human weaknesses have lead to the situation where now the “inherently human” abilities of social competence are of utmost importance when dealing with HITEC.

MANFRED MÜLLER

Captain Airbus A330 and A340, General Manager Flight Safety Research, Lufthansa and Lecturer on Risk Management at the University of Bremen

Plenary Session

SESSION 3Chair: Nichola Stevens, AstraZeneca

14.00 How can effective oversight be implemented to improve vendor quality in clinical development? Richard Scaife, Mitsubishi Pharma Europe

• What is oversight versus micromanagement?

• What are the fundamental processes involved?

• How many levels does it take to be effective?

• Is ‘Oversight’ prevention, cure or both?

14.45 QA Aspects/challenges with outsourced manufacturing including impact of updated Chapter 7 of EU GMP, and the Falsified Medicines Act Steve Porter, AstraZeneca

The presentation will cover the key aspects of the QA oversight of external manufacture including the areas of supplier selection, establishment, maintenance and termination. This will include the use of risk assessments to determine and justify the frequency and extent of interactions. The challenges of global supply chains will also be discussed.

15.30 Break

SESSION 4Chair: Jane Elliston, Battelle UK

16.00 Outsourcing – A study in human behaviour Colin Brown, Charles River Laboratories

• The evolution of outsourcing

• The three cornerstones – science/legislation/commerce

• The impact of venture capital

• Pharma goes to Hollywood

16.45 A day in the life of a CRO: Everyday considerations for outsourcing GLP Greg Furrow, WIL Research

• CRO as a test facility, test site and other multi-site study topics

• Sponsor inspections

• Sponsor specific requests

• Non-GLP compliance exceptions

• GLP training for Sponsors

• Everyday questions and answers

17.30 Outsourcing challenges from a ‘small’ biotech perspective Olivier Defert, AMAKEN NV

• Outsourcing market changes

• Limitations and challenges for a small company

• Expectations from a sponsor

• Case studies

Stream One: Outsourcing-Vendor

Oversight

WEDNESDAY 25th SEPTEMBER 2013

SESSION 3Chair: Catherine Liang, Ricerca BioSciences

14.00 Quality risk management, how does that impact QA workload? Alain Piton, Galderma R&D

• QRM, what is measured by QA?

• QRM, what are the potential uses of the measure?

- Audit program (internal and external)

- Qualification and validation

- Change control

- Deviations

- CAPA

• Does QRM impact QA’s workload and QA partners’ workload?

- Positively (optimise resources)

- Negatively (adds activity)

• What are the risks of overmanaging or undermanaging risks?

• Conclusion

14.45 Risk – What happens if we get it wrong? Barney Horne, Novartis Pharma AG

• Non-compliance versus catastrophic failures

• Risk indicators and detection errors

• Proactive and reactive risk management

15.30 Break

SESSION 4Chair: Kerstin Koenig, Eli Lilly

16.00 Risk – How does it fit across quality roles? Beat Widler, Widler and Schiemann Ltd

• Risk management, a change management challenge for:

- Monitors

- Auditors

- Regulatory Affairs

• What needs to change?

• How can it be changed?

• Why firing Frank Sinatra is key

16.45 Audit/quality strategies for GxP compliance Anne Ghent, Amgen Ltd

• Defining audit strategies

• Using indicators for risk assessments

• Assessing if the audit programme influences quality

• Measuring success

Stream Two: Risk Management

SESSION 3Chair: Rose Buot, Covance

14.00 Data exchanging Sylvia Kranich, SK Consulting

• Globalisation and technology

• Sponsor responsibilities/oversight

• Data protection

• Overview of vendor activities

• Considerations with respect to data transfers

14.45 Digitalisation of documents in a GxP regulated environment Michael Bursian, Grunenthal GmbH

• GxP requirements concerning a digitalisation that can replace the paper originals

• Components of processes and systems meeting the requirements

• Discussion of effort and profitability

15.30 Break

SESSION 4Chair: Paul Davidson, ICON

16.00 Can we destroy the paper? Gillian Gittens, Phlexglobal Ltd

Can we not only reduce the amount of paper documentation produced in a clinical trial, but can we destroy it as well?

Within the drug information association community for documents and records management, an effort was organised to develop the requirements for a framework for the destruction of paper. The goal of the framework is to provide a unified interpretation of the applicable laws, regulations and best practices that apply to a legally defensible, validated and regulatory compliant paper destruction process for GCP records.

• Presentation objectives:

- Discuss reducing paper

- Give an overview of the framework for paper destruction

- Learn about a case study of framework adoption

16.45 Quality and eTMF implementation Martin Thorley, Pfizer

• Program development to change and maintain scope of work for every project

• Managing constraints while implementing your eTMF system

• Change management – ‘mind set versus technology’

• Exploring configuration of an eTMF structure

Stream Three: Data Challenges

THURSDAY 26th SEPTEMBER 2013

SESSION 1Chair: Ulrich Schepers, BASF SE, Crop Protection

9.00 Harmonisation of Compliance Monitoring Authority expectations within the OECD GLP community Andrew Gray, MHRA

• OECD Working group initiatives to engage with stakeholders

• Implementation of an OECD electronic discussion group for industry

• Key topics identified during the first round of communication with stakeholders

• Next steps and progress so far

9.45 Organisation and procedures of Italian Monitoring Unit Annarita Meneguz, Istituto Superiore di Sanita (Italian national public health institute)

• Presentation of the Italian National GLP Monitoring Unit (IT-GLP), a governmental body which is part of the General Directorate of Prevention under the Department of Public Health Innovation of the Ministry of Health

• Description of the IT-GLP organisation including the Italian GLP Working Group for the coordination of the GLP activities (IT-GLP WG), established by a dedicated ministerial (General Directorate) provision

• Description of the inspectorate group illustrating its composition, training, experiences, backgrounds and the requirements of becoming Coordinator Inspectors

• Description of the IT-GLP web site, and the technical documents that schematically draw the IT-GLP operating modes described in the national GLP compliance monitoring program

10.30 Break

SESSION 2Chair: Ulrich Schepers, BASF SE, Crop Protection

11.00 GLP Round table discussion – Questions and answers Andrew Gray, MHRA (UK); Wolf Bulling, Federal Institute for Risk Assessment (Germany); Ronald Bauer, Austrian Agency for Health and Food Safety (Austria); Annarita Meneguz, National Public Health Institute (Italy); Dominique Abdon, Safety and Pharmacovigilance Inpection Unit, (France); Ulrich Schepers, BASF

Experts from European monitoring authorities and an industry representative will hold a round table discussion and give answers to questions collected before the conference. These questions will cover all areas of GLP such as regulations, guidelines, responsibilities of key functions, multi-site studies, IT topics, archiving, characterisation of test item, emerging technologies. Additionally questions raised by the audience during

the session will be discussed and answered. The session will be moderated by Stephen Harston, DGGF.

12.30 Lunch


13.45 Multi-site Studies – Who is really in control? Peter Davies, Consultant

• Role expectations

• Communication challenges

• Cultural influences

14.30 GLP Certification experience in China Marian Mutch, Covance

• Business etiquette in China

• History of Chinese State Food and Drug Administration (SFDA)

• GLP requirements of preclinical studies in China

• Observations of differences between international and Chinese SFDA GLP inspections in China

15.15 Break


15.45 Analysis of clinical trial samples: What is important for a GLP laboratory according to the EMA reflection paper? Ilona Fleischhauer, Fraunhofer Institute for Toxicology and Experimental Medicine

• Regulatory framework for analysis of clinical trial samples

• Scope and objective of the EMA reflection paper

• Main aspects of quality assurance in a laboratory performing the analysis of clinical trial samples

• Necessary steps for a GLP laboratory to be in compliance with the EMA reflection paper

16.30 GLP implementation at the University of Barcelona: The quality research service Carmen Navarro Aragay, Barcelona University

• The main challenges researchers had to face when trying to implement GLP in an academic framework

• The approach made at the University of Barcelona to provide support to researchers with different needs and expectations about quality compliance

• How the organisational structure built is able to assure the compliance with different standards

Stream A: Good Laboratory Practice

SESSION 1 – GMPChair: Rhona McAteer, TMQA

9.00 Risk based inspections Neil Raw, MHRA

• Introduction

• Identifying and collecting risk data

• Risk algorithm

• The planning process

9.45 ANSM Inspection division activities and developments Lionel Viornery, ANSM

The French National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé – ANSM) was created in 2011 in relation to the increased safety of medicines and healthcare products. The presentation will give an overview of ANSM’s finished products inspection activities and their measures against fraud.

10.30 Break

SESSION 2 – GMPChair: Nadine Frankenberg, BURECO AG

11.00 Preparation, organisation and follow-up of FDA inspections/differences with EU inspections Harald Wiedner, QuasSyCon GmbH

• General differences between EU and FDA inspections

• Concept of FDA inspections

• Inspection preparation

• Organisation/performance of the inspection

• Inspection psychology/influence of behaviour during inspections

• Most frequent inspection observations

• Wrap up and response

• Forms 483 and warning letters

• Follow-up of corrective actions

11.45 GDP: Gaps discovered and prioritised – A risk-based approach to the new EU GDP guidelines Sanjay Nadarajah, Inglasia Pharma Solutions

• The pharma supply chain is continually evolving

• The regulatory expectations are increasingly comprehensive

• Understanding your business processes versus regulatory standards

• Identifying the gaps and taking a risk-based approach – patient safety

12.30 Lunch

Stream B: Good Manufacturing Practice/Animal Health

SESSION 3 – Animal HealthChair: Marci Murphy, Boehringer Ingelheim Animal Health GmbH

13.45 Obtaining regulatory approval for clinical studies in Europe and requirements for clinical supplies management Claudia Schneider, Klifovet AG

• Animal test certificates in Europe

• Ethical committee’s involvement in granting of test permits in Europe (after implementation of Directive 2013/36/EC)

• Use of non-licensed clinical supplies in clinical studies including withdrawal periods

• Import requirements for clinical supplies

• Labelling of clinical supplies

• Specific requirements for documentation

14.30 Monitoring multinational studies Ivo Petersen, MSD Animal Health Innovation GmbH

• Planning and preparation of international studies

• Control of study conduct

• Study close-out and query management

• Common challenges in international studies

15.15 Break

SESSION 4 – Animal HealthChair: Marci Murphy, Boehringer Ingelheim Animal Health GmbH

15.45 Globalisation/harmonisation and its impact for sponsors Gareth Harris, Merck

• Overview of existing quality standards applicable to sponsors in the animal health industry (VICH, GxP and others) (Pharmaceuticals – biological – ecto-paraciticides)

• Differences associated with existing global quality standards

- Commercial

- Global product development

• Case studies

- Development of a global vaccine

- Manufacturing of an ecto-parisiticide

SESSION 1 – GCPChair: Christiane Hartlieb-Wallthor-Sano

9.00 Voluntary authorisation procedures and EU CT Regulation Hartmut Krafft, Paul-Ehrlich Institute

• Developments of clinical trial applications in Europe

• Voluntary harmonisation procedure

- Rules

- Results

- Future

• Aspects of the draft regulation on clinical trials

9.45 MHRA GCP Guide: Applicable across Europe? Colin Wilsher, Consultant

• MHRA produced a GCP guide on 24th September 2012, the first regulator to produce one

• How does it compare with EMA guidance?

• How applicable is it to studies in other European countries?

• What can we learn about GCP Inspectors expectations

10.30 Break

SESSION 2 – GCPChair: Brigitte Damour, Aptiv Solutions

11.00 Introduction to strategic knowledge management Victor Newman, Centre for Innovation, Imagination and Inspiration: University of Greenwich

All strategies are the product of a series of conscious or unconscious knowledge choices. Strategic Knowledge Management (SKM) is the deliberate selection and manipulation of different forms of knowledge to create and implement successful and innovative strategies.

The presentation will introduce key concepts and models:• The innovation context: Strategic

inflection points, value hierarchies and innovation thinking techniques

• Understanding the ecology of innovation leadership behaviours

• Recognising typical knowledge leadership ‘muscles’; making your knowledge work in the form of knowledge products and understanding your own organisation’s approach to knowledge

11.45 Auditing in the digital age Paul Strickland, Strickland Quality Assurance Ltd

• Remote auditing – a possibility?

• Digital data and audit signals

• What do the regulators think?

• How might you start to audit a cloud?

• What has really changed?

12.30 Lunch

SESSION 3 – GCP/Medical DevicesChair: Angelika Tillmann, Theorem Clinical Research

13.45 How secure are clinical data following ISO 14155? Judith Koehnen, Theorem Clinical Research GmbH & Co KG

• Comparison of ISO 14155 and ICH GCP

• Terms, principles and abbreviations

• Obligations of involved parties

• Challenges for global trials

14.30 The EU Medical Devices Directive and the role of Notified Bodies Matthew O’Donnell, BSI Group

• Notified Bodies and the Medical Devices Directive (93/42/EEC)

• ISO 13485 audits (QMS and microbiology)

• Device conformity assessment (design dossiers, technical files, changes, renewals)

• Risk management (ISO 14971)

• Post market surveillance (PMS) – active (post market clinical follow-up (PMCF), clinical evaluation) and passive (complaints, vigilance, registries)

• Future changes and the EU Medical Devices Regulation

15.15 Break

SESSION 4 – GCP/Non CommercialChair: Angelika Tillmann, Theorem Clinical Research

15.45 GCP, but not as we know it Patricia Henley, London School of Hygiene and Tropical Medicine

• Challenges of GCP in a variety of settings

• If it’s not by the book, is it still GCP?

• Can pharma learn from us in non commercial research?

16.30 Welcome to my planet: Non commercial research Joy Eldridge, University of Aberdeen/NHS Grampian

• A learning journey from the relatively safe haven of managing clinical trial quality systems in a commercial setting, to a new world of non commercial research

• Challenging perceptions regarding the role of the sponsor, the meaning of GCP and Quality Assurance

• An interactive session to test your knowledge of when the EU Clinical Trials Directive applies to clinical research involving drugs


Stream B: Good Manufacturing Practice/Animal Health Stream C: Good Clinical Practice/Medical Devices/Non Commercial

SESSION 1Chair: Helmuth Morgenthaler, DGGF

9.00 AGIT guidance on change management – Compliant change management in a GLP regulated environment Stephan Hassler, Harlan Laboratories Ltd

• Types of changes

• Change request

• Risk assessment

• Implementation of change

• Responsibilities

9.45 Vendor audit of an offshore IT development company – Process and experiences Michael Regehr, BASF Corporation

• Audit justification and team selection – risk assessment based on experience with vendor and current progress of project with vendor

• Audit preparations – checklists, advance document review, advance study

• Logistics of offshore travel – air travel, visas, hotels, security and food

• Experiences and discoveries – benefits of personal interactions with a vendor, relationship building, knowledge sharing by tours and rapid Q&A and cultural sensitivity

10.30 Break

SESSION 2Chair: Helmuth Morgenthaler, DGGF

11.00 Audit of IT services used in pharma R&D – Technical challenges, regulatory expectations, audit concepts Manu Reddy, Bayer HealthCare Pharmaceuticals

• Technical challenges due to cost reduction, rapid technology changes: Cloud software as a service, platform as service, data privacy, concept of global clinical studies

• Regulatory expectation: Patient data shall not be under control of sponsor – 3rd party concept supported

• Services used for clinical studies: Study specific validation at sponsor site (i.e. Bayer)

• Audit concept

- IT supplier audit to assure IT security, data privacy (e.g. ‘safe harbour’), core system development and validation, handling of 3rd parties used by IT supplier

- Audits of study-specific validation packages

- Risk-based approach

11.45 Application of Principles of GLP – Principles to a business process driven SOA environment – Prerequisites, flexibility and efficiency in a heterogeneous IT landscape Reinhard Dalz, Ernst & Young GmbH Wirtschaftsprüfungsgesellschaft

• In a modern business, business process modelling and service orientated architectures are used to align information technology (IT) to business needs

• Modelling is used to describe business processes in a common notation that is understandable for business and IT. Further requirements to IT capabilities are derived that are needed to support the processes. These can be seen as the functional requirements for the IT landscape

• Service oriented architectures describe principles that are used to structure IT landscapes as effective and efficient as possible. IT capabilities and access points to data are implemented in isolated services, which can be re-used in several business processes of the organisation. This allows a high degree of re-usage of these services and a single point of data

• For this constellation the presentation describes:

- If the application of GLP principles is possible in general, with consideration of the whole lifecycle of business processes and IT, but also IT architecture questions, and

- How GLP and non GLP components and services of an IT landscape can be combined in a efficient and flexible manner

12.30 Lunch

SESSION 3Chair: Liz Adams, GlaxoSmithKline

13.45 Applying GAMP 5 principles to data in R&D – How to maintain data integrity within GCP processes Frank Henrichmann, PAREXEL International GmbH

• Overview of key processes and systems used in clinical trials

• Essential quality aspects to be considered

• Dataflow from the investigator to the sponsor and beyond

• Challenges in controlling and maintaining SaaS and Cloud Systems

• Applying a risk-based validation approach to the live cycles of GCP systems

Stream D: Information Technology

14.30 Management of mobile devices in a GxP regulated environment – Security and data integrity considerations Sarah Pickersgill, Celerion

• The wide choice of ‘healthcare apps’

• Challenges of the GxP environment

• Can data integrity really be assured?

• Which security principles apply?

15.15 Break

SESSION 4Chair: Liz Adams, GlaxoSmithKline

15.45 Contracted IT services – Advantages and disadvantages for a GxP environment Karen Taylor, AstraZeneca

• Background to the programme

- Size and scope of the change

- Complexity and speed

• Challenges of building quality and compliance requirements into activities

- The foundation for quality and compliance

- Quality and compliance team structure and being agile

• Assurance

- Tools used in the programme

- Audit and assurance activities

16.30 Generation of user requirements specifications to establish a tailored GxP compliant LIMS for a typical bioanalytical CRO – Highlights and pitfalls Timo Kretzschmar, Pharm-analyt Labor GmbH

• Brief description of the preconditions - a self-established ‘Mini-LIMS’ - some examples

• Process of selection of the provider/contractor of the URS - selection criteria

• Clarification together with the provider as to which way the creation of a (new) LIMS should go (with respect to programming)

• Analysis of the main (sample) process and the auxiliary processes (chemicals, test equipment, instruments, documentation, etc.)

• Discussion of the draft analysis with accountable persons from Analytics/ IT/QA

• Finalisation after meeting with laboratory management and explanation of last questions

• Adaption of skills for further possible validation process (of QA) by attending respective training

• Forwarding of URS to potential providers


QUALITY ACROSS EUROPE

2013

Stream E: Pharmacovigilance/Medical Devices

SESSION 1 – PVChair: Allison Jack, GlaxoSmithKline

9.00 Master file requirements, expectations from a regulatory perspective Diane Hallé, ANSM

• Share feedback over one year's experience of reviewing pharmacovigilance system master file (PSMF) submitted in the context of PV inspection

• Present the expectations of a PV inspectorate regarding the management, the format and content of PSMF

9.45 Implementing quality management systems Maria Wishart, GlaxoSmithKline

A description of the challenges of implementing a quality management system including:

• Metrics

• Development of quality manual

• Managing deviations

10.30 Break

SESSION 2 – PVChair: Pam Bones, Allergan Ltd

11.00 Implementation of Good Pharmacovigilance Practices Guidelines Modules 1-1V – A CRO QA perspective Helen Powell, inVentiv Health Clinical

• Sharing information relating to:

- Experiences and challenges

- Interfaces and expectations of MAHs

- Plans for the future

11.45 The use of relational modelling as a tool to detect safety signals amongst patients’ web posts James Sawyer, Prism Ideas Ltd

• Non-specific data capture and aggregation from the internet

• Data sorting and enrichment to support patient profiling

• Contextual analysis and outcomes reporting

- Differences between analytic methods

- Uses beyond spontaneous patient reports

• The future of PV using internet reports

12.30 Lunch

SESSION 3 – PVChair: Bianca Scholz, Scholz Consulting

13.45 Managing patient safety in the EU – One year of experience with the new PV legislation Monika Pietrek, Pietrek Associates GmbH

• Operational challenges in signal management, generation of RMPs and periodic safety reports

• Interaction with Pharmacovigilance Risk Assessment Committee (PRAC)

• Transparency to the public

• Feedback from PV audits and inspections

14.30 European risk management systems Susanne Becker, Spm2

The new legislation has changed the format and expectations on European risk management plans.

The presentation will review:

• The changes in legal requirements – what’s new?

• The change in format and content – what are the effects on planning and conduct of risk management plans?

• Experiences with the new format – how to implement the new EU-RMP, lessons learned?

15.15 Break

SESSION 4 – PV/Medical DevicesChair: Bianca Scholz, Scholz Consulting

15.45 Differences in regulatory pathways for combination products and the impact thereof in pharmacovigilance Henny Koch, QIMP Management Systems Ltd

• Combination products involve components that are regulated and controlled following different pathways

• Medical device aspects within clinical development are regulated following the requirements of ISO 14155

• Clinical investigations on medicinal products shall comply with GCP

• Essential differences in the set up and control of clinical investigations may lead to unawareness of potential patient risk in pharmacovigilance

• Regulatory differences and their impact are explained

16.30 Medical Device Vigilance Lindsay Watt, GlaxoSmithKline

This presentation will review the existing European vigilance requirements and present some ideas about how these can be audited effectively and efficiently.


Join your fellow delegates for a special evening at the Maritim Hotel, 26th September 2013. Pre-dinner drinks at 7pm followed by dinner (including wine) at 7.30pm. After dinner, dance the night away until midnight.

Dress code: black tie/suit and ballgowns.

The cost of the dinner dance is included in the full delegate registration fee. Two day delegates can purchase a ticket when registering for the conference.

CONFERENCE DINNER DANCE THURSDAY 26TH SEPTEMBER 2013


Plenary Session

FRIDAY 27th SEPTEMBER 2013

SESSION 1 EUROPE AND WHAT THE FUTURE HOLDSChairs: Steffen Koenig, Laurent Bouillot and Louise Handy

9.45 The future in Europe for big pharma and how regulations impact us everyday Nigel Hamilton, Sanofi

• Operating a global pharmaceutical company in the context of non-global regulation

• Efforts towards international harmonisation of regulations

• Consideration of the current regulatory environment

• Strategic importance of future regulatory harmonisation

SESSION 2 CONFERENCE REVIEW AND SUMMARYChairs: Steffen Koenig, Laurent Bouillot and Louise Handy

11.00 Summary of the conference – What have we learned? Andrew Waddell, TMQA

A summary of the last three days of the 1st European QA Conference.

11.45 Conference closing presentation Steffen Koenig (DGGF), Laurent Bouillott (SOFAQ) and Louise Handy (RQA)


MEETING ORGANISERCSM, Congress & Seminar ManagementIndustriestrasse 3582194 Groebenzell, Germany

Phone +49 8142 570183Fax +49 8142 54735Email [email protected] www.csm-congress.de

CONFERENCE DELEGATE REGISTRATIONDelegate fees

Full Delegate Package

Until 16th August 2013

Member of DGGF/RQA/SOFAQ/ Other QA Societies €580 plus VAT (19%)

Non Member €640 plus VAT (19%)

From 17th August 2013



Full Delegate Package includes welcome reception on Wednesday evening and the reception and dinner dance on Thursday evening.

If booking 5 delegates from one company then the 5th delegate would be free of charge. Only applies if all delegates are booked at the same time.

Two Day Delegate Package



Two Day Package includes welcome reception on Wednesday (if Wednesday is one of your days).

All delegates are recommended to register directly online at: www.csm-congress.de/congresses/eqac All data will be transferred via a secure (SSL) connection.

HOTEL ACCOMMODATIONHotel accommodation at the Maritim Hotel should also be booked online at the following address: https://secure.netbookerng.com/singleShopper.jsp? acctid=5459537&promocode=1STQA

Hotel rates

Single occupancy in a single room€158 per person per night including breakfast.

Double occupancy in a double room €205 per room per night including breakfast.

Hotel check-in time is from 15.00hrs andcheck-out time is 12.00hrs.

Visit the hotel Maritim at:

www.maritim.co.uk/en/hotels/germany/hotel-bonn

TERMS AND CONDITIONSAll conference cancellations must be received in writing to CSM, Congress & Seminar Management.

For all cancellations an administrative fee of €100 plus VAT will be charged.

No refunds can be made for cancellations received after 16th August 2013.

Registrations may be transferred to another person at any time. Please notify CSM as soon as possible.

Please note that the organisers cannot be held responsible for any liabilities caused by the potential cancellation of the conference due to unforeseen circumstances. The organiser cannot accept liability for accidents, injuries and losses that might occur. The conference programme is subject to modifications.

INFORMATION

Hotel Maritim cancellations

Accommodation cancellations will be free of charge, if received no later than 14 days prior to arrival by 18.00hrs (local hotel time). Otherwise 90% of the full stay will be charged. Booking amendments will be handled as a cancel/re-book.Cancellation policy as well as further information on reservations is provided by the Maritim Hotel during the online booking process – see link opposite.

TRANSPORTATIONThe Maritim Hotel is situated centrally between Bonn and Bad Godesberg.

• Distance to Bonn Central Station: 5km

• Distance to Cologne/Bonn Airport: 20km

• Distance to motorway: 1km

Taxi fares

• From Cologne/Bonn airport: approx €43

• From Bonn Central station: approx €12

• From ICE station Siegburg: approx €27

The Airport Express Bus SB60 runs between the airport and Bonn Central Station (journey time: 30 minutes; fare: €7.20). For more information visit: www.swb-busundbahn.de

Public transportation

www.vrsinfo.de/englisch/the-vrs/vrs-about-us.html

Route Hotel Bonn

http://goo.gl/maps/UrvYI

Other links

Tourist Office Bonnwww.bonn.de

Airport Cologne/Bonnwww.koeln-bonn-airport.de

Public transportwww.bahn.de

quality across europe 2013 - sarqa.com€¦ · the european qa conference programme committee...

Documents