1. Europäische QA Konferenz und 18. Jahrestagung der DGGF

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European QA Conference Website: EU Konferenz

Die 18. Jahrestagung 2013 und 1. Europäische QA Konferenz fand vom 25. bis 27. September 2013 im

Maritim Hotel, Bonn statt.

...

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Programm

Mittwoch, 25. September 2013

08:00

- 12:45

Plenary Session

SAAL MARITIM

08:00

Conference registration

09:00

- 09:15

Opening address

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

09:15

- 10:45

Session 1 - KEYNOTE SPEAKER

Chairs: Steffen König, Laurent Bouillot and Louise Handy

09:15

- 10:15

Risk Management - Lessons learnt from aviation

Müller, Manfred; Lufthansa

10:15

- 10:45

Break

10:45

- 12:45

Session 2

Chair: König Steffen; IST

10:45

- 11:45

Changes in European Regulation

Sweeney, Fergus; EMA

11:45

- 12:45

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

about the concept

Schwarz, Gabriele; BfARM

12:45

- 14:00

Lunch

14:00

- 18:15

Stream One - Outsourcing - Vendor Oversight

SAAL REGER

14:00

- 15:30

Stream One - Outsourcing - Vendor Oversight - Session 3

Chair: Stevens, Nichola; Astra Zeneca

14:00

- 14:45

How can effective oversight be implemented to improve vendor

quality in clinical development?

Scaife, Richard; Mitsubishi Pharma Europe

14:45

- 15:30

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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16:00

- 18:15

Stream One - Outsourcing - Vendor Oversight - Session 4

Chair: Elliston, Jane; Battelle UK

16:00

- 16:45

Outsourcing - A study in human behaviour

Brown, Colin, Charles River Laboratories

16:45

- 17:30

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

outsourcing GLP

Furrow, Greg; WIL Research

17:30

- 18:15

Outsourcing challenges from a 'small' biotech perspective

Defert, Olivier; AMAKEN NV

14:00

- 17:30

Stream Two - Risk Management

SAAL MARITIM

14:00

- 16:00

Stream Two - Risk Management - Session 3

Chair: Liang, Catherine; Ricerca BioSciences

14:00

- 14:45

Quality risk management, how does that impact QA workload?

Piton, Alain; Galderma R&D

14:45

- 15:30

Risk - What happens if we get it wrong?

Horne, Barney; Novartis Pharma AG

15:30

- 16:00

Break

16:00

- 17:30

Stream Two - Risk Management - Session 4

Chair: König, Kerstin; Merck

16:00

- 16:45

Risk - How does it fit across quality roles?

Widler, Beat; Widler and Schiemann Ltd

16:45

- 17:30

Audit/quality strategies for GxP compliance

Ghent, Anne; Amgen Ltd

14:00

- 17:30

Stream Three - Data Challenges

SAAL SCHUMANN

14:00

- 16:00

Stream Three - Data Challenges - Session 3

Chair: Buot, Rose; Covance

14:00

- 14:45

Data exchanging

Kranich, Sylvia; SK Consulting

14:45

- 15:30

Digitalisation of documents in a GxP environment

Bursian, Michael; Grunenthal GmbH

15:30

- 16:00

Break

16:00

- 17:30

Stream Three - Data Challenges - Session 4

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Programm

16:00

- 16:45

Can we destroy the paper?

Gittens, Gillian; Phlexglobal Ltd

16:45

- 17:30

Quality and eTMF implementation

Thorley, Martin; Pfizer

18:15

- 19:15

Meet the Delegate Drinks Reception

Donnerstag, 26. September 2013

09:00

- 17:15

Stream A: Good Laboratory Practice

SAAL MARITIM

09:00

- 11:00

Stream A: GLP - Session 1

Chair: Schepers, Ulrich; BASF SE, Crop Protection

09:00

- 09:45

Hamonisation of Compliance Monitoring Authority expectations

within OECD GLP community

Gray, Andrew; MHRA

09:45

- 10:30

Organisation and procedures of Italian Monitoring Authority

Meneguz, Annarita; Italian National Public Health

10:30

- 11:00

Break

11:00

- 13:45

Stream A: GLP - Session 2

Chair: Schepers, Ulrich; BASF SE, Crop Protection

11:00

- 12:30

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

13:45

- 15:45

Stream A: GLP - Session 3

Chair: Liang, Catherine; Ricerca BioSciences

13:45

- 14:30

Multi-site studies - Who is really in control?

Davies, Peter; Peter Davies Associates

14:30

- 15:15

GLP certification experience in China

Mutch, Marian; Covance

15:15

- 15:45

Break

15:45

- 17:15

Stream A: GLP - Session 4

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15:45

- 16:30

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

16:30

- 17:15

GLP Implementation at the University of Barcelona: The quality

research service

Navarro Aragay, Carmen; Barcelona University

19:30

PRE DINNER DRINKS RECEPTION followed by DINNER

DANCE

09:00

- 17:15

Stream B: Good Manufacturing Practice/Animal Health

SAAL KOCH

09:00

- 11:00

Stream B: Session 1 - GMP

Chair: McAteer, Rhona; TMQA

09:00

- 09:45

Risk-based inspections

Stanbrook, Rebecca; MHRA

09:45

- 10:30

ANSM Inspection division activities and developments

Viornery, Lional; ANSM

10:30

- 11:00

Break

11:00

- 13:45

Stream B: Session 2 - GMP

Chair: Frankenberg, Nadine; Bureco AG

11:00

- 11:45

Preparation, organisation and follow-up of FDA

inspections/differences with EU inspections

Wiedner, Harald;QuasSyCon GmbH

11:45

- 12:30

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

the new EU GDP guidelines

Nadarajah, Sanjay; Inglasia Pharma Solutions

13:45

- 15:45

Stream B: Session 3 - Animal Health

Chair: Murphy, Marci; Boehringer Ingelheim Animal Health GmbH

13:45

- 14:30

Obtaining regulatory approval for clinical studies in Europe and

requirements for clinical supplies management

Schneider, Claudia; Klifovet AG

14:30

- 15:15

Monitoring multinational studies

Petersen, Ivo; MSD Animal Health Innovation GmbH

15:15

- 15:45

Break

15:45

- 17:15

Stream B: Session 4 - Animal Health

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Programm

15:45

- 16:30

Globalisation/harmonisation and its impact for sponsors

Harris, Gareth; Merck

16:30

- 17:15

Help! What is EDC?

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

19:30

PRE DINNER DRINKS RECEPTION followed by DINNER

DANCE

09:00

- 17:15

Stream C: Good Clinical Practice/Medical Devices/Non

Commercial

SAAL SCHUMANN

09:00

- 11:00

Stream C: Session 1 - GCP

Chair: Hartlieb-Wallthor-Sano Christiane

09:00

- 09:45

Voluntary authorisation procedures and EU CT Regulation

Szalay, Gudrun; Paul-Ehrlich Institute

09:45

- 10:30

MHRA GCP Guide: Applicable across Europe?

Wilsher, Colin; Consultant

10:30

- 11:00

Break

11:00

- 13:45

Stream C: Session 2 - GCP

Chair: Damour, Brigitte; Aptiv Solutions

11:00

- 11:45

Introduction to strategic knowledge management

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

11:45

- 12:30

Auditing in the digital age

Strickland, Paul; Strickland Quality Assurance Ltd

13:45

- 15:45

Stream C: Session 3 - GCP/Medical Devices

Chair: Tillmann, Angelika; Theorem Clinical Research

13:45

- 14:30

How secure are clinical data following ISO 14155?

Koehnen, Judith; Theorem Clinical Research GmbH & Co KG

14:30

- 15:15

The EU Medical Devices Directive and the role of Notified Bodies

O'Donnell, Matthew; BSI Group

15:15

- 15:45

Break

15:45

- 17:15

Stream C: Session 4 - GCP/Non Commercial

Chair: Tillmann, Angelika; Theorem Clinical Research

15:45

- 16:30

GCP, but not as we know it

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16:30

- 17:15

Welcome to my planet: Non commercial research

Eldridge, Joy; University of Aberdeen/NHS Grampian

19:30

PRE DINNER DRINKS RECEPTION followed by DINNER

DANCE

09:00

- 17:15

Stream D: Information Technology

SAAL REGER

09:00

- 11:00

Stream D: Information Technology - Session 1

Chair: Morgenthaler, Helmuth; DGGF

09:00

- 09:45

AGIT Guidance on change management - Compliant change

management in a GLP regulated environment

Hassler, Stephan; Harlan Laboratories Ltd

09:45

- 10:30

Vendor audit of an offshore IT development company - Process

and experiences

Regehr, Michael; BASF Corporation

10:30

- 11:00

Break

11:00

- 13:45

Stream D: Information Technology - Session 2

Chair: Morgenthaler, Helmuth; DGGF

11:00

- 11:45

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

regulatory expectations, audit concepts

Reddy, Manu; Bayer HealthCare Pharmaceuticals

11:45

- 12:30

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

13:45

- 15:45

Stream D: Information Technology - Session 3

Chair: Stevens, Nichola; AstraZeneca

13:45

- 14:30

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

within GCP Processes

Henrichmann, Frank; PAREXEL International GmbH

14:30

- 15:15

Management of mobile devices in a GxP regulated environment

-Security and date integrity considerations

Montgomery, Chris; Boehringer Ingelheim

15:15

- 15:45

Break

15:45

- 17:15

Stream D: Information Technology - Session 4

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Programm

15:45

- 16:30

Contracted IT services - Advantages and disadvantages for a GxP

environment

Taylor, Karen; AstraZeneca

16:30

- 17:15

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

19:30

PRE DINNER DRINKS RECEPTION followed by DINNER

DANCE

09:00

- 17:15

Stream E: Pharmacovigilance/Medical Devices

SAAL HAYDN

09:00

- 11:00

Stream E: Session 1 - PV

Chair: Jack, Allison; GlaxoSmithKline

09:00

- 09:45

Master file requirements, expectations from a regulatory

perspective

Halle, Dianne; ANSM

09:45

- 10:30

Implementing quality management systems

Wishart, Maria; GlaxoSmithKline

10:30

- 11:00

Break

11:00

- 14:45

Stream E: Session 2 - PV

Chair: Bones, Pam; Allergan Ltd

11:00

- 11:45

Implementation of Good Pharmacovigilance Practices Guidelines

Modules 1-1V - A CRO QA perspective

Powell, Helen; InVentiv Health Clinical

11:45

- 12:30

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

amongst patients' web posts

Sawyer, James; Prism Ideas Ltd

13:45

- 15:45

Stream E: Session 3 - PV

Chair: Scholz, Bianca; Scholz Consulting

13:45

- 14:30

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

the new PV legislation

Pietrek, Monika; Pietrek Associates GmbH

14:30

- 15:15

European risk management systems

Becker Susanne; Spm2

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15:45

- 17:15

Stream E: Session 4 - Medical Devices

Chair: Scholz, Bianca; Scholz Consulting

15:45

- 16:30

Differences in regulatory pathways for combination products and

the impact thereof in pharmacovigilance

Koch, Henry; QIMP Management Systems Ltd

16:30

- 17:15

Medical Device vigilance

Watt, Lindsay; GlaxoSmithKline

19:30

PRE DINNER DRINKS RECEPTION followed by DINNER

DANCE

Freitag, 27. September 2013

09:45

- 12:00

Plenary Session

SAAL MARITIM

09:45

- 11:00

Plenary Session 1 - EUROPE AND WHAT THE FUTURE HOLDS

Chairs: Steffen König, Laurent Bouillot and Louise Handy

09:45

- 10:30

The future in Europe for big pharma and how regulations impact

us everyday

Hamilton, Nigel; Sanofi

10:30

- 11:00

Break

11:00

- 12:00

Plenary Session 2 - CONFERENCE REVIEW AND SUMMARY

Chairs: Steffen König, Laurent Bouillot and Louise Handy

11:00

- 11:45

Summary of the conference - What have we learned

Waddell, Andrew; TMQA

11:45

- 12:00

Conference closing presentation

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

(10)

Vorträge

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

Furrow, Greg; WIL Research

Mittwoch, 25. September 2013, 16:45 - 17:30

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

environment

Hassler, Stephan; Harlan Laboratories Ltd

Donnerstag, 26. September 2013, 09:00 - 09:45

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

Donnerstag, 26. September 2013, 15:45 - 16:30

ANSM Inspection division activities and developments

Viornery, Lional; ANSM

Donnerstag, 26. September 2013, 09:45 - 10:30

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

Donnerstag, 26. September 2013, 11:45 - 12:30

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

Henrichmann, Frank; PAREXEL International GmbH

Donnerstag, 26. September 2013, 13:45 - 14:30

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

concepts

Reddy, Manu; Bayer HealthCare Pharmaceuticals

Donnerstag, 26. September 2013, 11:00 - 11:45

Audit/quality strategies for GxP compliance

Ghent, Anne; Amgen Ltd

Mittwoch, 25. September 2013, 16:45 - 17:30

Auditing in the digital age

Strickland, Paul; Strickland Quality Assurance Ltd

Donnerstag, 26. September 2013, 11:45 - 12:30

Can we destroy the paper?

Gittens, Gillian; Phlexglobal Ltd

Mittwoch, 25. September 2013, 16:00 - 16:45

Changes in European Regulation

Sweeney, Fergus; EMA

Mittwoch, 25. September 2013, 10:45 - 11:45

Conference closing presentation

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

(11)

Contracted IT services - Advantages and disadvantages for a GxP environment

Taylor, Karen; AstraZeneca

Donnerstag, 26. September 2013, 15:45 - 16:30

Data exchanging

Kranich, Sylvia; SK Consulting

Mittwoch, 25. September 2013, 14:00 - 14:45

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

pharmacovigilance

Koch, Henry; QIMP Management Systems Ltd

Donnerstag, 26. September 2013, 15:45 - 16:30

Digitalisation of documents in a GxP environment

Bursian, Michael; Grunenthal GmbH

Mittwoch, 25. September 2013, 14:45 - 15:30

European risk management systems

Becker Susanne; Spm2

Donnerstag, 26. September 2013, 14:30 - 15:15

GCP, but not as we know it

Henley, Patricia; London School of Hygiene and Tropical Medicine

Donnerstag, 26. September 2013, 15:45 - 16:30

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

Nadarajah, Sanjay; Inglasia Pharma Solutions

Donnerstag, 26. September 2013, 11:45 - 12:30

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

Donnerstag, 26. September 2013, 16:30 - 17:15

Globalisation/harmonisation and its impact for sponsors

Harris, Gareth; Merck

Donnerstag, 26. September 2013, 15:45 - 16:30

GLP certification experience in China

Mutch, Marian; Covance

Donnerstag, 26. September 2013, 14:30 - 15:15

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

Navarro Aragay, Carmen; Barcelona University

Donnerstag, 26. September 2013, 16:30 - 17:15

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)

Vorträge

Hamonisation of Compliance Monitoring Authority expectations within OECD GLP community

Gray, Andrew; MHRA

Donnerstag, 26. September 2013, 09:00 - 09:45

Help! What is EDC?

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

Donnerstag, 26. September 2013, 16:30 - 17:15

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

Scaife, Richard; Mitsubishi Pharma Europe

Mittwoch, 25. September 2013, 14:00 - 14:45

How secure are clinical data following ISO 14155?

Koehnen, Judith; Theorem Clinical Research GmbH & Co KG

Donnerstag, 26. September 2013, 13:45 - 14:30

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

perspective

Powell, Helen; InVentiv Health Clinical

Donnerstag, 26. September 2013, 11:00 - 11:45

Implementing quality management systems

Wishart, Maria; GlaxoSmithKline

Donnerstag, 26. September 2013, 09:45 - 10:30

Introduction to strategic knowledge management

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

Donnerstag, 26. September 2013, 11:00 - 11:45

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

considerations

Montgomery, Chris; Boehringer Ingelheim

Donnerstag, 26. September 2013, 14:30 - 15:15

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

Pietrek, Monika; Pietrek Associates GmbH

Donnerstag, 26. September 2013, 13:45 - 14:30

Master file requirements, expectations from a regulatory perspective

Halle, Dianne; ANSM

Donnerstag, 26. September 2013, 09:00 - 09:45

Medical Device vigilance

Watt, Lindsay; GlaxoSmithKline

Donnerstag, 26. September 2013, 16:30 - 17:15

MHRA GCP Guide: Applicable across Europe?

Wilsher, Colin; Consultant

Donnerstag, 26. September 2013, 09:45 - 10:30

Monitoring multinational studies

Petersen, Ivo; MSD Animal Health Innovation GmbH

(13)

Multi-site studies - Who is really in control?

Davies, Peter; Peter Davies Associates

Donnerstag, 26. September 2013, 13:45 - 14:30

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

management

Schneider, Claudia; Klifovet AG

Donnerstag, 26. September 2013, 13:45 - 14:30

Organisation and procedures of Italian Monitoring Authority

Meneguz, Annarita; Italian National Public Health

Donnerstag, 26. September 2013, 09:45 - 10:30

Outsourcing - A study in human behaviour

Brown, Colin, Charles River Laboratories

Mittwoch, 25. September 2013, 16:00 - 16:45

Outsourcing challenges from a 'small' biotech perspective

Defert, Olivier; AMAKEN NV

Mittwoch, 25. September 2013, 17:30 - 18:15

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

Wiedner, Harald;QuasSyCon GmbH

Donnerstag, 26. September 2013, 11:00 - 11:45

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

EU GMP, and the Falsified Medicines Act

Porter, Steve; AstraZeneca, UK

Mittwoch, 25. September 2013, 14:45 - 15:30

Quality and eTMF implementation

Thorley, Martin; Pfizer

Mittwoch, 25. September 2013, 16:45 - 17:30

Quality risk management, how does that impact QA workload?

Piton, Alain; Galderma R&D

Mittwoch, 25. September 2013, 14:00 - 14:45

Risk - How does it fit across quality roles?

Widler, Beat; Widler and Schiemann Ltd

Mittwoch, 25. September 2013, 16:00 - 16:45

Risk - What happens if we get it wrong?

Horne, Barney; Novartis Pharma AG

Mittwoch, 25. September 2013, 14:45 - 15:30

Risk Management - Lessons learnt from aviation

Müller, Manfred; Lufthansa

Mittwoch, 25. September 2013, 09:15 - 10:15

Risk-based inspections

Stanbrook, Rebecca; MHRA

(14)

Vorträge

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

Schwarz, Gabriele; BfARM

Mittwoch, 25. September 2013, 11:45 - 12:45

Summary of the conference - What have we learned

Waddell, Andrew; TMQA

Freitag, 27. September 2013, 11:00 - 11:45

The EU Medical Devices Directive and the role of Notified Bodies

O'Donnell, Matthew; BSI Group

Donnerstag, 26. September 2013, 14:30 - 15:15

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

Hamilton, Nigel; Sanofi

Freitag, 27. September 2013, 09:45 - 10:30

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

Sawyer, James; Prism Ideas Ltd

Donnerstag, 26. September 2013, 11:45 - 12:30

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

Regehr, Michael; BASF Corporation

Donnerstag, 26. September 2013, 09:45 - 10:30

Voluntary authorisation procedures and EU CT Regulation

Szalay, Gudrun; Paul-Ehrlich Institute

Donnerstag, 26. September 2013, 09:00 - 09:45

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

Donnerstag, 26. September 2013, 11:00 - 12:30

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

GLP Round table discussion - Questions and answers

Donnerstag, 26. September 2013, 11:00 - 12:30

Becker Susanne; Spm2

European risk management systems

Donnerstag, 26. September 2013, 14:30 - 15:15

Brown, Colin, Charles River Laboratories

Outsourcing - A study in human behaviour

Mittwoch, 25. September 2013, 16:00 - 16:45

Bulling, Wolf ; Federal Institute for Risk Assessment, Germany

GLP Round table discussion - Questions and answers

Donnerstag, 26. September 2013, 11:00 - 12:30

Bursian, Michael; Grunenthal GmbH

Digitalisation of documents in a GxP environment

Mittwoch, 25. September 2013, 14:45 - 15:30

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

Donnerstag, 26. September 2013, 11:45 - 12:30

Davies, Peter; Peter Davies Associates

Multi-site studies - Who is really in control?

Donnerstag, 26. September 2013, 13:45 - 14:30

Defert, Olivier; AMAKEN NV

Outsourcing challenges from a 'small' biotech perspective

Mittwoch, 25. September 2013, 17:30 - 18:15

DGGF - Steffen König

Conference closing presentation

Freitag, 27. September 2013, 11:45 - 12:00

Opening address

Mittwoch, 25. September 2013, 09:00 - 09:15

Eldridge, Joy; University of Aberdeen/NHS Grampian

Welcome to my planet: Non commercial research

(16)

Referenten

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?

Donnerstag, 26. September 2013, 15:45 - 16:30

Furrow, Greg; WIL Research

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

Mittwoch, 25. September 2013, 16:45 - 17:30

Ghent, Anne; Amgen Ltd

Audit/quality strategies for GxP compliance

Mittwoch, 25. September 2013, 16:45 - 17:30

Gittens, Gillian; Phlexglobal Ltd

Can we destroy the paper?

Mittwoch, 25. September 2013, 16:00 - 16:45

Gray, Andrew Gray; MHRA

GLP Round table discussion - Questions and answers

Donnerstag, 26. September 2013, 11:00 - 12:30

Gray, Andrew; MHRA

Hamonisation of Compliance Monitoring Authority expectations within OECD GLP community

Donnerstag, 26. September 2013, 09:00 - 09:45

Halle, Dianne; ANSM

Master file requirements, expectations from a regulatory perspective

Donnerstag, 26. September 2013, 09:00 - 09:45

Hamilton, Nigel; Sanofi

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

Freitag, 27. September 2013, 09:45 - 10:30

Harris, Gareth; Merck

Globalisation/harmonisation and its impact for sponsors

Donnerstag, 26. September 2013, 15:45 - 16:30

Hassler, Stephan; Harlan Laboratories Ltd

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

Donnerstag, 26. September 2013, 09:00 - 09:45

Henley, Patricia; London School of Hygiene and Tropical Medicine

GCP, but not as we know it

Donnerstag, 26. September 2013, 15:45 - 16:30

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?

Mittwoch, 25. September 2013, 14:45 - 15:30

Koch, Henry; QIMP Management Systems Ltd

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

Donnerstag, 26. September 2013, 15:45 - 16:30

Koehnen, Judith; Theorem Clinical Research GmbH & Co KG

How secure are clinical data following ISO 14155?

Donnerstag, 26. September 2013, 13:45 - 14:30

Kranich, Sylvia; SK Consulting

Data exchanging

Mittwoch, 25. September 2013, 14:00 - 14:45

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

Donnerstag, 26. September 2013, 16:30 - 17:15

Meneguz, Annarita; Italian National Public Health

Organisation and procedures of Italian Monitoring Authority

Donnerstag, 26. September 2013, 09:45 - 10:30

Meneguz, Annarita; National Public Health Institute, Italy

GLP Round table discussion - Questions and answers

Donnerstag, 26. September 2013, 11:00 - 12:30

Montgomery, Chris; Boehringer Ingelheim

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

Donnerstag, 26. September 2013, 14:30 - 15:15

Müller, Manfred; Lufthansa

Risk Management - Lessons learnt from aviation

Mittwoch, 25. September 2013, 09:15 - 10:15

Mutch, Marian; Covance

GLP certification experience in China

Donnerstag, 26. September 2013, 14:30 - 15:15

Nadarajah, Sanjay; Inglasia Pharma Solutions

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

Donnerstag, 26. September 2013, 11:45 - 12:30

(18)

Referenten

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

Donnerstag, 26. September 2013, 16:30 - 17:15

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

Introduction to strategic knowledge management

Donnerstag, 26. September 2013, 11:00 - 11:45

O'Donnell, Matthew; BSI Group

The EU Medical Devices Directive and the role of Notified Bodies

Donnerstag, 26. September 2013, 14:30 - 15:15

Petersen, Ivo; MSD Animal Health Innovation GmbH

Monitoring multinational studies

Donnerstag, 26. September 2013, 14:30 - 15:15

Pietrek, Monika; Pietrek Associates GmbH

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

Donnerstag, 26. September 2013, 13:45 - 14:30

Piton, Alain; Galderma R&D

Quality risk management, how does that impact QA workload?

Mittwoch, 25. September 2013, 14:00 - 14:45

Porter, Steve; AstraZeneca, UK

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

Mittwoch, 25. September 2013, 14:45 - 15:30

Powell, Helen; InVentiv Health Clinical

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

Donnerstag, 26. September 2013, 11:00 - 11:45

Reddy, Manu; Bayer HealthCare Pharmaceuticals

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

Donnerstag, 26. September 2013, 11:00 - 11:45

Regehr, Michael; BASF Corporation

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

Donnerstag, 26. September 2013, 09:45 - 10:30

RQA - Louise Handy

Conference closing presentation

Freitag, 27. September 2013, 11:45 - 12:00

Opening address

Mittwoch, 25. September 2013, 09:00 - 09:15

(19)

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

Donnerstag, 26. September 2013, 11:45 - 12:30

Scaife, Richard; Mitsubishi Pharma Europe

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

Mittwoch, 25. September 2013, 14:00 - 14:45

Schepers, Ulrich Schepers; BASF

GLP Round table discussion - Questions and answers

Donnerstag, 26. September 2013, 11:00 - 12:30

Schneider, Claudia; Klifovet AG

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

Donnerstag, 26. September 2013, 13:45 - 14:30

Schwarz, Gabriele; BfARM

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

Mittwoch, 25. September 2013, 11:45 - 12:45

SoFAQ - Laurent Bouillot

Conference closing presentation

Freitag, 27. September 2013, 11:45 - 12:00

Opening address

Mittwoch, 25. September 2013, 09:00 - 09:15

Stanbrook, Rebecca; MHRA

Risk-based inspections

Donnerstag, 26. September 2013, 09:00 - 09:45

Strickland, Paul; Strickland Quality Assurance Ltd

Auditing in the digital age

Donnerstag, 26. September 2013, 11:45 - 12:30

Sweeney, Fergus; EMA

Changes in European Regulation

Mittwoch, 25. September 2013, 10:45 - 11:45

Szalay, Gudrun; Paul-Ehrlich Institute

Voluntary authorisation procedures and EU CT Regulation

Donnerstag, 26. September 2013, 09:00 - 09:45

Taylor, Karen; AstraZeneca

Contracted IT services - Advantages and disadvantages for a GxP environment

Donnerstag, 26. September 2013, 15:45 - 16:30

(20)

Referenten

Quality and eTMF implementation

Mittwoch, 25. September 2013, 16:45 - 17:30

Viornery, Lional; ANSM

ANSM Inspection division activities and developments

Donnerstag, 26. September 2013, 09:45 - 10:30

Waddell, Andrew; TMQA

Summary of the conference - What have we learned

Freitag, 27. September 2013, 11:00 - 11:45

Watt, Lindsay; GlaxoSmithKline

Medical Device vigilance

Donnerstag, 26. September 2013, 16:30 - 17:15

Widler, Beat; Widler and Schiemann Ltd

Risk - How does it fit across quality roles?

Mittwoch, 25. September 2013, 16:00 - 16:45

Wiedner, Harald;QuasSyCon GmbH

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

Donnerstag, 26. September 2013, 11:00 - 11:45

Wilsher, Colin; Consultant

MHRA GCP Guide: Applicable across Europe?

Donnerstag, 26. September 2013, 09:45 - 10:30

Wishart, Maria; GlaxoSmithKline

Implementing quality management systems

Donnerstag, 26. September 2013, 09:45 - 10:30

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

Help! What is EDC?

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