1st European QA Conference and 18th Annual Meeting of DGGF

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European QA Conference website: EU QA conference

The 18th International Meeting and 1st European QA Conference took place September 25th - 27th,

Maritim Hotel, Bonn, Germany

...

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Programme

Wednesday, September 25, 2013

8:00 AM

- 12:45 PM

Plenary Session

SAAL MARITIM

8:00 AM

Conference registration

9:00 AM

- 9:15 AM

Opening address

DGGF - Steffen König SoFAQ - Laurent Bouillot RQA - Louise Handy

9:15 AM

- 10:45 AM

Session 1 - KEYNOTE SPEAKER

Chairs: Steffen König, Laurent Bouillot and Louise Handy

9:15 AM

- 10:15 AM

Risk Management - Lessons learnt from aviation

Müller, Manfred; Lufthansa

10:15 AM

- 10:45 AM

Break

10:45 AM

- 12:45 PM

Session 2

Chair: König Steffen; IST

10:45 AM

- 11:45 AM

Changes in European Regulation

Sweeney, Fergus; EMA

11:45 AM

- 12:45 PM

Risk-based quality management of clinical trials- What is special

about the concept

Schwarz, Gabriele; BfARM

12:45 PM

- 2:00 PM

Lunch

2:00 PM

- 6:15 PM

Stream One - Outsourcing - Vendor Oversight

SAAL REGER

2:00 PM

- 3:30 PM

Stream One - Outsourcing - Vendor Oversight - Session 3

Chair: Stevens, Nichola; Astra Zeneca

2:00 PM

- 2:45 PM

How can effective oversight be implemented to improve vendor

quality in clinical development?

Scaife, Richard; Mitsubishi Pharma Europe

2:45 PM

- 3:30 PM

QA Aspects/challenges with outsourced manufacturing including

impact of updated Chapter 7 of EU GMP, and the Falsified

Medicines Act

Porter, Steve; AstraZeneca, UK

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4:00 PM

- 6:15 PM

Stream One - Outsourcing - Vendor Oversight - Session 4

Chair: Elliston, Jane; Battelle UK

4:00 PM

- 4:45 PM

Outsourcing - A study in human behaviour

Brown, Colin, Charles River Laboratories

4:45 PM

- 5:30 PM

A day in the life of a CRO: Everyday considerations for

outsourcing GLP

Furrow, Greg; WIL Research

5:30 PM

- 6:15 PM

Outsourcing challenges from a 'small' biotech perspective

Defert, Olivier; AMAKEN NV

2:00 PM

- 5:30 PM

Stream Two - Risk Management

SAAL MARITIM

2:00 PM

- 4:00 PM

Stream Two - Risk Management - Session 3

Chair: Liang, Catherine; Ricerca BioSciences

2:00 PM

- 2:45 PM

Quality risk management, how does that impact QA workload?

Piton, Alain; Galderma R&D

2:45 PM

- 3:30 PM

Risk - What happens if we get it wrong?

Horne, Barney; Novartis Pharma AG

3:30 PM

- 4:00 PM

Break

4:00 PM

- 5:30 PM

Stream Two - Risk Management - Session 4

Chair: König, Kerstin; Merck

4:00 PM

- 4:45 PM

Risk - How does it fit across quality roles?

Widler, Beat; Widler and Schiemann Ltd

4:45 PM

- 5:30 PM

Audit/quality strategies for GxP compliance

Ghent, Anne; Amgen Ltd

2:00 PM

- 5:30 PM

Stream Three - Data Challenges

SAAL SCHUMANN

2:00 PM

- 4:00 PM

Stream Three - Data Challenges - Session 3

Chair: Buot, Rose; Covance

2:00 PM

- 2:45 PM

Data exchanging

Kranich, Sylvia; SK Consulting

2:45 PM

- 3:30 PM

Digitalisation of documents in a GxP environment

Bursian, Michael; Grunenthal GmbH

3:30 PM

- 4:00 PM

Break

4:00 PM

- 5:30 PM

Stream Three - Data Challenges - Session 4

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Programme

4:00 PM

- 4:45 PM

Can we destroy the paper?

Gittens, Gillian; Phlexglobal Ltd

4:45 PM

- 5:30 PM

Quality and eTMF implementation

Thorley, Martin; Pfizer

6:15 PM

- 7:15 PM

Meet the Delegate Drinks Reception

Thursday, September 26, 2013

9:00 AM

- 5:15 PM

Stream A: Good Laboratory Practice

SAAL MARITIM

9:00 AM

- 11:00 AM

Stream A: GLP - Session 1

Chair: Schepers, Ulrich; BASF SE, Crop Protection

9:00 AM

- 9:45 AM

Hamonisation of Compliance Monitoring Authority expectations

within OECD GLP community

Gray, Andrew; MHRA

9:45 AM

- 10:30 AM

Organisation and procedures of Italian Monitoring Authority

Meneguz, Annarita; Italian National Public Health

10:30 AM

- 11:00 AM

Break

11:00 AM

- 1:45 PM

Stream A: GLP - Session 2

Chair: Schepers, Ulrich; BASF SE, Crop Protection

11:00 AM

- 12:30 PM

GLP Round table discussion - Questions and answers

Gray, Andrew Gray; MHRA

Bulling, Wolf ; Federal Institute for Risk Assessment, Germany Bauer, Ronald; Austrian Agency for Health and Food Safety, Austria Meneguz, Annarita; National Public Health Institute, Italy

Abdon, Dominique; Safety and Pharmacovigilance Inspection Unit, France Schepers, Ulrich Schepers; BASF

1:45 PM

- 3:45 PM

Stream A: GLP - Session 3

Chair: Liang, Catherine; Ricerca BioSciences

1:45 PM

- 2:30 PM

Multi-site studies - Who is really in control?

Davies, Peter; Peter Davies Associates

2:30 PM

- 3:15 PM

GLP certification experience in China

Mutch, Marian; Covance

3:15 PM

- 3:45 PM

Break

3:45 PM

- 5:15 PM

Stream A: GLP - Session 4

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3:45 PM

- 4:30 PM

Analysis of clinical trial samples: What is important for a GLP

laboratory according to the EMA reflection paper?

Fleischhauer, Ilona; Fraunhofer Institute for Toxicology and Experimental Medicine

4:30 PM

- 5:15 PM

GLP Implementation at the University of Barcelona: The quality

research service

Navarro Aragay, Carmen; Barcelona University

7:30 PM

PRE DINNER DRINKS RECEPTION followed by DINNER

DANCE

9:00 AM

- 5:15 PM

Stream B: Good Manufacturing Practice/Animal Health

SAAL KOCH

9:00 AM

- 11:00 AM

Stream B: Session 1 - GMP

Chair: McAteer, Rhona; TMQA

9:00 AM

- 9:45 AM

Risk-based inspections

Stanbrook, Rebecca; MHRA

9:45 AM

- 10:30 AM

ANSM Inspection division activities and developments

Viornery, Lional; ANSM

10:30 AM

- 11:00 AM

Break

11:00 AM

- 1:45 PM

Stream B: Session 2 - GMP

Chair: Frankenberg, Nadine; Bureco AG

11:00 AM

- 11:45 AM

Preparation, organisation and follow-up of FDA

inspections/differences with EU inspections

Wiedner, Harald;QuasSyCon GmbH

11:45 AM

- 12:30 PM

GDP: Gaps discovered and prioritised - a risk-based approach to

the new EU GDP guidelines

Nadarajah, Sanjay; Inglasia Pharma Solutions

1:45 PM

- 3:45 PM

Stream B: Session 3 - Animal Health

Chair: Murphy, Marci; Boehringer Ingelheim Animal Health GmbH

1:45 PM

- 2:30 PM

Obtaining regulatory approval for clinical studies in Europe and

requirements for clinical supplies management

Schneider, Claudia; Klifovet AG

2:30 PM

- 3:15 PM

Monitoring multinational studies

Petersen, Ivo; MSD Animal Health Innovation GmbH

3:15 PM

- 3:45 PM

Break

3:45 PM

- 5:15 PM

Stream B: Session 4 - Animal Health

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Programme

3:45 PM

- 4:30 PM

Globalisation/harmonisation and its impact for sponsors

Harris, Gareth; Merck

4:30 PM

- 5:15 PM

Help! What is EDC?

Wolf, Oliver; Lohlein & Wolf Vet Research & Jo McKelvie, EVITA Services

7:30 PM

PRE DINNER DRINKS RECEPTION followed by DINNER

DANCE

9:00 AM

- 5:15 PM

Stream C: Good Clinical Practice/Medical Devices/Non

Commercial

SAAL SCHUMANN

9:00 AM

- 11:00 AM

Stream C: Session 1 - GCP

Chair: Hartlieb-Wallthor-Sano Christiane

9:00 AM

- 9:45 AM

Voluntary authorisation procedures and EU CT Regulation

Szalay, Gudrun; Paul-Ehrlich Institute

9:45 AM

- 10:30 AM

MHRA GCP Guide: Applicable across Europe?

Wilsher, Colin; Consultant

10:30 AM

- 11:00 AM

Break

11:00 AM

- 1:45 PM

Stream C: Session 2 - GCP

Chair: Damour, Brigitte; Aptiv Solutions

11:00 AM

- 11:45 AM

Introduction to strategic knowledge management

Newman, Victor; Centre for Innovation, Imagination and Inspiration: University of Greenwich

11:45 AM

- 12:30 PM

Auditing in the digital age

Strickland, Paul; Strickland Quality Assurance Ltd

1:45 PM

- 3:45 PM

Stream C: Session 3 - GCP/Medical Devices

Chair: Tillmann, Angelika; Theorem Clinical Research

1:45 PM

- 2:30 PM

How secure are clinical data following ISO 14155?

Koehnen, Judith; Theorem Clinical Research GmbH & Co KG

2:30 PM

- 3:15 PM

The EU Medical Devices Directive and the role of Notified Bodies

O'Donnell, Matthew; BSI Group

3:15 PM

- 3:45 PM

Break

3:45 PM

- 5:15 PM

Stream C: Session 4 - GCP/Non Commercial

Chair: Tillmann, Angelika; Theorem Clinical Research

3:45 PM

- 4:30 PM

GCP, but not as we know it

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4:30 PM

- 5:15 PM

Welcome to my planet: Non commercial research

Eldridge, Joy; University of Aberdeen/NHS Grampian

7:30 PM

PRE DINNER DRINKS RECEPTION followed by DINNER

DANCE

9:00 AM

- 5:15 PM

Stream D: Information Technology

SAAL REGER

9:00 AM

- 11:00 AM

Stream D: Information Technology - Session 1

Chair: Morgenthaler, Helmuth; DGGF

9:00 AM

- 9:45 AM

AGIT Guidance on change management - Compliant change

management in a GLP regulated environment

Hassler, Stephan; Harlan Laboratories Ltd

9:45 AM

- 10:30 AM

Vendor audit of an offshore IT development company - Process

and experiences

Regehr, Michael; BASF Corporation

10:30 AM

- 11:00 AM

Break

11:00 AM

- 1:45 PM

Stream D: Information Technology - Session 2

Chair: Morgenthaler, Helmuth; DGGF

11:00 AM

- 11:45 AM

Audit of IT services used pharma R&D - Technical challenges,

regulatory expectations, audit concepts

Reddy, Manu; Bayer HealthCare Pharmaceuticals

11:45 AM

- 12:30 PM

Application of principles of GLP - Principles to a business process

driven SOA environment - Prerequisites, flexibility and efficiency in

a heterogeneous IT landscape

Dalz, Reinhard; Ernst & Young GmbH Wirtschaftsprufungsgeesellschaft

1:45 PM

- 3:45 PM

Stream D: Information Technology - Session 3

Chair: Stevens, Nichola; AstraZeneca

1:45 PM

- 2:30 PM

Applying GAMP 5 to data in R&D - How to maintain data integrity

within GCP Processes

Henrichmann, Frank; PAREXEL International GmbH

2:30 PM

- 3:15 PM

Management of mobile devices in a GxP regulated environment

-Security and date integrity considerations

Montgomery, Chris; Boehringer Ingelheim

3:15 PM

- 3:45 PM

Break

3:45 PM

- 5:15 PM

Stream D: Information Technology - Session 4

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Programme

3:45 PM

- 4:30 PM

Contracted IT services - Advantages and disadvantages for a GxP

environment

Taylor, Karen; AstraZeneca

4:30 PM

- 5:15 PM

Generation of user requirements specifications to establish a

tailored GxP compliant LIMS for a typical bioanalytical CRO

-Highlights and pitfalls

Kretzschmar, Timo; Pharm-analyt Labor GmbH

7:30 PM

PRE DINNER DRINKS RECEPTION followed by DINNER

DANCE

9:00 AM

- 5:15 PM

Stream E: Pharmacovigilance/Medical Devices

SAAL HAYDN

9:00 AM

- 11:00 AM

Stream E: Session 1 - PV

Chair: Jack, Allison; GlaxoSmithKline

9:00 AM

- 9:45 AM

Master file requirements, expectations from a regulatory

perspective

Halle, Dianne; ANSM

9:45 AM

- 10:30 AM

Implementing quality management systems

Wishart, Maria; GlaxoSmithKline

10:30 AM

- 11:00 AM

Break

11:00 AM

- 2:45 PM

Stream E: Session 2 - PV

Chair: Bones, Pam; Allergan Ltd

11:00 AM

- 11:45 AM

Implementation of Good Pharmacovigilance Practices Guidelines

Modules 1-1V - A CRO QA perspective

Powell, Helen; InVentiv Health Clinical

11:45 AM

- 12:30 PM

The use of relational modelling as a tool to detect safety signals

amongst patients' web posts

Sawyer, James; Prism Ideas Ltd

1:45 PM

- 3:45 PM

Stream E: Session 3 - PV

Chair: Scholz, Bianca; Scholz Consulting

1:45 PM

- 2:30 PM

Managing patient safety in the EU - One year of experience with

the new PV legislation

Pietrek, Monika; Pietrek Associates GmbH

2:30 PM

- 3:15 PM

European risk management systems

Becker Susanne; Spm2

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3:45 PM

- 5:15 PM

Stream E: Session 4 - Medical Devices

Chair: Scholz, Bianca; Scholz Consulting

3:45 PM

- 4:30 PM

Differences in regulatory pathways for combination products and

the impact thereof in pharmacovigilance

Koch, Henry; QIMP Management Systems Ltd

4:30 PM

- 5:15 PM

Medical Device vigilance

Watt, Lindsay; GlaxoSmithKline

7:30 PM

PRE DINNER DRINKS RECEPTION followed by DINNER

DANCE

Friday, September 27, 2013

9:45 AM

- 12:00 PM

Plenary Session

SAAL MARITIM

9:45 AM

- 11:00 AM

Plenary Session 1 - EUROPE AND WHAT THE FUTURE HOLDS

9:45 AM

- 10:30 AM

The future in Europe for big pharma and how regulations impact

us everyday

Hamilton, Nigel; Sanofi

10:30 AM

- 11:00 AM

Break

11:00 AM

- 12:00 PM

Plenary Session 2 - CONFERENCE REVIEW AND SUMMARY

11:00 AM

- 11:45 AM

Summary of the conference - What have we learned

Waddell, Andrew; TMQA

11:45 AM

- 12:00 PM

Conference closing presentation

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Titles

A day in the life of a CRO: Everyday considerations for outsourcing GLP

Furrow, Greg; WIL Research

Wednesday, September 25, 2013, 4:45 PM - 5:30 PM

AGIT Guidance on change management - Compliant change management in a GLP regulated

environment

Hassler, Stephan; Harlan Laboratories Ltd

Thursday, September 26, 2013, 9:00 AM - 9:45 AM

Analysis of clinical trial samples: What is important for a GLP laboratory according to the EMA

reflection paper?

Fleischhauer, Ilona; Fraunhofer Institute for Toxicology and Experimental Medicine

Thursday, September 26, 2013, 3:45 PM - 4:30 PM

ANSM Inspection division activities and developments

Viornery, Lional; ANSM

Application of principles of GLP Principles to a business process driven SOA environment

-Prerequisites, flexibility and efficiency in a heterogeneous IT landscape

Dalz, Reinhard; Ernst & Young GmbH Wirtschaftsprufungsgeesellschaft

Thursday, September 26, 2013, 11:45 AM - 12:30 PM

Applying GAMP 5 to data in R&D - How to maintain data integrity within GCP Processes

Henrichmann, Frank; PAREXEL International GmbH

Audit of IT services used pharma R&D - Technical challenges, regulatory expectations, audit

concepts

Reddy, Manu; Bayer HealthCare Pharmaceuticals

Audit/quality strategies for GxP compliance

Ghent, Anne; Amgen Ltd

Auditing in the digital age

Strickland, Paul; Strickland Quality Assurance Ltd

Can we destroy the paper?

Gittens, Gillian; Phlexglobal Ltd

Changes in European Regulation

Sweeney, Fergus; EMA

Wednesday, September 25, 2013, 10:45 AM - 11:45 AM

Conference closing presentation

(11)

Contracted IT services - Advantages and disadvantages for a GxP environment

Taylor, Karen; AstraZeneca

Data exchanging

Kranich, Sylvia; SK Consulting

Differences in regulatory pathways for combination products and the impact thereof in

pharmacovigilance

Koch, Henry; QIMP Management Systems Ltd

Digitalisation of documents in a GxP environment

Bursian, Michael; Grunenthal GmbH

European risk management systems

Becker Susanne; Spm2

GCP, but not as we know it

Henley, Patricia; London School of Hygiene and Tropical Medicine

GDP: Gaps discovered and prioritised - a risk-based approach to the new EU GDP guidelines

Nadarajah, Sanjay; Inglasia Pharma Solutions

Generation of user requirements specifications to establish a tailored GxP compliant LIMS for a

typical bioanalytical CRO - Highlights and pitfalls

Kretzschmar, Timo; Pharm-analyt Labor GmbH

Globalisation/harmonisation and its impact for sponsors

Harris, Gareth; Merck

GLP certification experience in China

Mutch, Marian; Covance

GLP Implementation at the University of Barcelona: The quality research service

Navarro Aragay, Carmen; Barcelona University

GLP Round table discussion - Questions and answers

Gray, Andrew Gray; MHRA

Bulling, Wolf ; Federal Institute for Risk Assessment, Germany Bauer, Ronald; Austrian Agency for Health and Food Safety, Austria Meneguz, Annarita; National Public Health Institute, Italy

Abdon, Dominique; Safety and Pharmacovigilance Inspection Unit, France Schepers, Ulrich Schepers; BASF

(12)

Titles

Hamonisation of Compliance Monitoring Authority expectations within OECD GLP community

Gray, Andrew; MHRA

Help! What is EDC?

Wolf, Oliver; Lohlein & Wolf Vet Research & Jo McKelvie, EVITA Services

How can effective oversight be implemented to improve vendor quality in clinical development?

Scaife, Richard; Mitsubishi Pharma Europe

How secure are clinical data following ISO 14155?

Koehnen, Judith; Theorem Clinical Research GmbH & Co KG

Implementation of Good Pharmacovigilance Practices Guidelines Modules 1-1V - A CRO QA

perspective

Powell, Helen; InVentiv Health Clinical

Implementing quality management systems

Wishart, Maria; GlaxoSmithKline

Introduction to strategic knowledge management

Newman, Victor; Centre for Innovation, Imagination and Inspiration: University of Greenwich

Management of mobile devices in a GxP regulated environment - Security and date integrity

considerations

Montgomery, Chris; Boehringer Ingelheim

Managing patient safety in the EU - One year of experience with the new PV legislation

Pietrek, Monika; Pietrek Associates GmbH

Master file requirements, expectations from a regulatory perspective

Halle, Dianne; ANSM

Medical Device vigilance

Watt, Lindsay; GlaxoSmithKline

MHRA GCP Guide: Applicable across Europe?

Wilsher, Colin; Consultant

Monitoring multinational studies

Petersen, Ivo; MSD Animal Health Innovation GmbH

(13)

Multi-site studies - Who is really in control?

Davies, Peter; Peter Davies Associates

Obtaining regulatory approval for clinical studies in Europe and requirements for clinical supplies

management

Schneider, Claudia; Klifovet AG

Organisation and procedures of Italian Monitoring Authority

Meneguz, Annarita; Italian National Public Health

Outsourcing - A study in human behaviour

Brown, Colin, Charles River Laboratories

Outsourcing challenges from a 'small' biotech perspective

Defert, Olivier; AMAKEN NV

Preparation, organisation and follow-up of FDA inspections/differences with EU inspections

Wiedner, Harald;QuasSyCon GmbH

QA Aspects/challenges with outsourced manufacturing including impact of updated Chapter 7 of

EU GMP, and the Falsified Medicines Act

Porter, Steve; AstraZeneca, UK

Quality and eTMF implementation

Thorley, Martin; Pfizer

Quality risk management, how does that impact QA workload?

Piton, Alain; Galderma R&D

Risk - How does it fit across quality roles?

Widler, Beat; Widler and Schiemann Ltd

Risk - What happens if we get it wrong?

Horne, Barney; Novartis Pharma AG

Risk Management - Lessons learnt from aviation

Müller, Manfred; Lufthansa

Risk-based inspections

Stanbrook, Rebecca; MHRA

(14)

Titles

Risk-based quality management of clinical trials- What is special about the concept

Schwarz, Gabriele; BfARM

Wednesday, September 25, 2013, 11:45 AM - 12:45 PM

Summary of the conference - What have we learned

Waddell, Andrew; TMQA

Friday, September 27, 2013, 11:00 AM - 11:45 AM

The EU Medical Devices Directive and the role of Notified Bodies

O'Donnell, Matthew; BSI Group

The future in Europe for big pharma and how regulations impact us everyday

Hamilton, Nigel; Sanofi

The use of relational modelling as a tool to detect safety signals amongst patients' web posts

Sawyer, James; Prism Ideas Ltd

Vendor audit of an offshore IT development company - Process and experiences

Regehr, Michael; BASF Corporation

Voluntary authorisation procedures and EU CT Regulation

Szalay, Gudrun; Paul-Ehrlich Institute

Welcome to my planet: Non commercial research

Eldridge, Joy; University of Aberdeen/NHS Grampian

(15)

Abdon, Dominique; Safety and Pharmacovigilance Inspection Unit, France

GLP Round table discussion - Questions and answers

Bauer, Ronald; Austrian Agency for Health and Food Safety, Austria

Becker Susanne; Spm2

European risk management systems

Brown, Colin, Charles River Laboratories

Outsourcing - A study in human behaviour

Bulling, Wolf ; Federal Institute for Risk Assessment, Germany

Bursian, Michael; Grunenthal GmbH

Digitalisation of documents in a GxP environment

Dalz, Reinhard; Ernst & Young GmbH Wirtschaftsprufungsgeesellschaft

Application of principles of GLP - Principles to a business process driven SOA environment - Prerequisites, flexibility and efficiency in a heterogeneous IT landscape

Davies, Peter; Peter Davies Associates

Multi-site studies - Who is really in control?

Defert, Olivier; AMAKEN NV

Outsourcing challenges from a 'small' biotech perspective

DGGF - Steffen König

Conference closing presentation

Friday, September 27, 2013, 11:45 AM - 12:00 PM

Opening address

Eldridge, Joy; University of Aberdeen/NHS Grampian

Welcome to my planet: Non commercial research

(16)

Presenters

Fleischhauer, Ilona; Fraunhofer Institute for Toxicology and Experimental Medicine

Analysis of clinical trial samples: What is important for a GLP laboratory according to the EMA reflection paper?

Furrow, Greg; WIL Research

A day in the life of a CRO: Everyday considerations for outsourcing GLP

Ghent, Anne; Amgen Ltd

Audit/quality strategies for GxP compliance

Gittens, Gillian; Phlexglobal Ltd

Can we destroy the paper?

Gray, Andrew Gray; MHRA

Gray, Andrew; MHRA

Hamonisation of Compliance Monitoring Authority expectations within OECD GLP community

Halle, Dianne; ANSM

Master file requirements, expectations from a regulatory perspective

Hamilton, Nigel; Sanofi

The future in Europe for big pharma and how regulations impact us everyday

Harris, Gareth; Merck

Globalisation/harmonisation and its impact for sponsors

Hassler, Stephan; Harlan Laboratories Ltd

AGIT Guidance on change management - Compliant change management in a GLP regulated environment

Henley, Patricia; London School of Hygiene and Tropical Medicine

GCP, but not as we know it

Henrichmann, Frank; PAREXEL International GmbH

Applying GAMP 5 to data in R&D - How to maintain data integrity within GCP Processes

(17)

Horne, Barney; Novartis Pharma AG

Risk - What happens if we get it wrong?

Koch, Henry; QIMP Management Systems Ltd

Differences in regulatory pathways for combination products and the impact thereof in pharmacovigilance

Koehnen, Judith; Theorem Clinical Research GmbH & Co KG

How secure are clinical data following ISO 14155?

Kranich, Sylvia; SK Consulting

Data exchanging

Kretzschmar, Timo; Pharm-analyt Labor GmbH

Generation of user requirements specifications to establish a tailored GxP compliant LIMS for a typical bioanalytical CRO -Highlights and pitfalls

Meneguz, Annarita; Italian National Public Health

Organisation and procedures of Italian Monitoring Authority

Meneguz, Annarita; National Public Health Institute, Italy

Montgomery, Chris; Boehringer Ingelheim

Management of mobile devices in a GxP regulated environment - Security and date integrity considerations

Müller, Manfred; Lufthansa

Risk Management - Lessons learnt from aviation

Mutch, Marian; Covance

GLP certification experience in China

Nadarajah, Sanjay; Inglasia Pharma Solutions

GDP: Gaps discovered and prioritised - a risk-based approach to the new EU GDP guidelines

(18)

Presenters

GLP Implementation at the University of Barcelona: The quality research service

Newman, Victor; Centre for Innovation, Imagination and Inspiration: University of Greenwich

Introduction to strategic knowledge management

O'Donnell, Matthew; BSI Group

The EU Medical Devices Directive and the role of Notified Bodies

Petersen, Ivo; MSD Animal Health Innovation GmbH

Monitoring multinational studies

Pietrek, Monika; Pietrek Associates GmbH

Managing patient safety in the EU - One year of experience with the new PV legislation

Piton, Alain; Galderma R&D

Quality risk management, how does that impact QA workload?

Porter, Steve; AstraZeneca, UK

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

Powell, Helen; InVentiv Health Clinical

Implementation of Good Pharmacovigilance Practices Guidelines Modules 1-1V - A CRO QA perspective

Reddy, Manu; Bayer HealthCare Pharmaceuticals

Audit of IT services used pharma R&D - Technical challenges, regulatory expectations, audit concepts

Regehr, Michael; BASF Corporation

Vendor audit of an offshore IT development company - Process and experiences

RQA - Louise Handy

Opening address

(19)

The use of relational modelling as a tool to detect safety signals amongst patients' web posts

Scaife, Richard; Mitsubishi Pharma Europe

How can effective oversight be implemented to improve vendor quality in clinical development?

Schepers, Ulrich Schepers; BASF

Schneider, Claudia; Klifovet AG

Obtaining regulatory approval for clinical studies in Europe and requirements for clinical supplies management

Schwarz, Gabriele; BfARM

Risk-based quality management of clinical trials- What is special about the concept

Wednesday, September 25, 2013, 11:45 AM - 12:45 PM

SoFAQ - Laurent Bouillot

Opening address

Stanbrook, Rebecca; MHRA

Risk-based inspections

Strickland, Paul; Strickland Quality Assurance Ltd

Auditing in the digital age

Sweeney, Fergus; EMA

Changes in European Regulation

Szalay, Gudrun; Paul-Ehrlich Institute

Voluntary authorisation procedures and EU CT Regulation

Taylor, Karen; AstraZeneca

Contracted IT services - Advantages and disadvantages for a GxP environment

(20)

Presenters

Quality and eTMF implementation

Viornery, Lional; ANSM

ANSM Inspection division activities and developments

Waddell, Andrew; TMQA

Summary of the conference - What have we learned

Watt, Lindsay; GlaxoSmithKline

Medical Device vigilance

Widler, Beat; Widler and Schiemann Ltd

Risk - How does it fit across quality roles?

Wiedner, Harald;QuasSyCon GmbH

Preparation, organisation and follow-up of FDA inspections/differences with EU inspections

Wilsher, Colin; Consultant

MHRA GCP Guide: Applicable across Europe?

Wishart, Maria; GlaxoSmithKline

Implementing quality management systems

Wolf, Oliver; Lohlein & Wolf Vet Research & Jo McKelvie, EVITA Services

Help! What is EDC?