2014 Europe Annual Conference

2014 Europe Annual Conference

2014 Europe Annual Conference

 

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Conference Schedule

Tuesday, 29 April 2014

08.00 – 08.50 Breakfast Networking Reception
08.50 – 09.10

Opening of the meeting by the Chair Jean-Francois Duliere, Pharmaceutical Process Technologist, Technip, and Representative from Regierungspraesidium Darmstadt / Regional Council Darmstadta

Welcome by Nancy Berg, CEO, ISPE
Foreword by Dr. Thomas Zimmer, Vice President, European Operations, ISPE

09.10 – 09.50

Introduction of the Speakers: Jean-Francois Duliere, Pharmaceutical Process Technologist, Technip

1st Keynote Speech: Regulatory View

Speaker: Dr. Fergus Sweeney, Head of Inspections & Human Medicines Pharmacovigilance Division, European Medicines Agency (EMA)

09.50 – 10.30

2nd Keynote Speech: Customer View

Future Challenges in Biopharma

Speaker: Prof. Dr. Wolfram Carius, Senior Vice President Biopharma Strategy and Member of the Global Leadership Team, Sanofi Frankfurt

10.30 – 11.00 Networking Break
11.00 – 11.35

Introduction of the Speakers: Representative from Regierungspraesidium Darmstadt / Regional Council Darmstadt

3rd Keynote Speech: Industry View

Speaker: John Pinion, Global Head of PT Quality & Compliance, Roche

11.35 – 12.10

4th Keynote Speech

Changing the Quality Culture - How Do We Prepare for the Next 10 Years?

Speaker: Carol Bye, Head Pharmaceutical Sciences Quality Assurance Global Quality Operations, Pfizer

12.10 – 13.00 Lunch

Track 1: QbD - Reality Today? Implementation and Beyond

Theme 1: Implementation of QbD
13.00 – 13.40

The Major Challenges of QbD Implementation

Speaker: Dr. Jean-Louis Robert, Head of Department, LNS

13.40 – 14.20

Feedback and Learning from EMA, EFPIA - QbD Workshop

Speaker: Dr. Evdokia Korakianiti, Head of Procedure Management Department, EMA

14.20 – 15.00

Learning from the Joint FDA-EMA Assessment

Speaker: Dr. Graham Cook, Sr. Director, Pfizer

15.00 – 15.30 Networking Break
15.30 – 16.10

US FDA Approach to QbD, Aligned with EU?

Speaker: Roger Nosal, Vice President CGMC, Pfizer

16.10 – 16.50

QbD for Biotech (Vs. Small Molecule): Same Principle, Same Implementation?

Speaker: Wendy Zwolenski-Lambert, Global Validation Leader, Technical Operations, Novartis

16.50 – 18.00 Networking Drinks
19.00 – 22.00 Dinner

Track 2: QRM

Theme 1: QRM Applications and Current Challenges
13.00 – 13.40

QRM in PQS - Regulatory Approach (PIC/S Perspective)

Speaker: Dr. Jacques Morenas, Deputy Director, Inspectorate and Companies Department, ANSM

13.40 – 14.20

QRM Based Regulation

Speaker: Mark Birse, Group Manager GMDP, MHRA

14.20 – 15.00

QRM - Best Industry Practices

Speaker: Martin Lush, Vice President, NSF

15.00 – 15.30 Networking Break
15.30 – 16.10

Industry Approach to QRM in the EU - Quality Unit Perspective

Speaker: Dr. John Kerridge, Quality Leader, EU Quality Assurance Systems and External Advocacy, Eli Lilly

16.10 – 16.50

Panel Discussion Challenges on QRM in Pharmaceutical Industry

Moderator: Bryan Wright, European Regulatory Advisor, ISPE
Panellists: Speaker line-up from QRM Applications and Current Challenges Topic

16.50 – 18.00 Networking Drinks
19.00 – 22.00 Dinner

Track 3: Facilities of the Future

Theme 1: Facilities for API and OSD in the Future
13.00 – 13.15

Opening Session - Setting the Scene

Jean-Francois Duliere, Pharmaceutical Process Technologist, Technip
Gert Moelgaard, Vice President, Strategic Development, NNE Pharmaplan

13.15 – 14.05

ConsiGma™, a Flexible Continuous Manufacturing Platform: From API to Coated Tablet

Speaker: Kris Schoeters, Product Manager Continuous Processing, GEA

14.05 – 15.00

Continuous Manufacturing of Direct Compression Tablets: Design, Installation, and Commercial Operatione

Speaker: Frank Streil, Head of TSA (Technology & Scienticic Affairs), Teva

15.00 – 15.30 Networking Break
15.30 – 16.10

Continuous Manufacturing Technology Theme - Case: Novartis MIT Cooperation

Speaker: Manfred Maeder, Global Head TRD QA, Novartis

16.10 – 16.50

Achieving High OEE in Aseptic Production

Speaker: Gerald Buerkle, Director Pharmaceutical Production, Vetter Pharma-Fertigung

16.50 – 18.00 Networking Drinks
19.00 – 22.00 Dinner

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Wednesday, 30 April 2014

Track 1: QbD - Reality Today? Implementation and Beyond

Theme 1: Implementation of QbD (cont.)
07.50 – 08.30

Morning Coffee

08.30 – 09.10

How the Principle of QbD Could Apply to Current Portfolio? Criteria of Choice? Sharing Experience?

Speaker: Dr. Lorenz Liesum, Senior Process Analytical Expert (PAT), Novartis

09.10 – 09.50

Life Cycle Management of CMC and Change Management

Speaker: Dr. David Tainsh, Chief Product Quality Officer, GSK

09.50 – 10.20 Networking Break
10.20 – 11.00

Pharmacopeia in the Era of QbD

Speaker: Dr. Susanne Keitel, Director, EDQM

11.00 – 11.30

QbD in the Global Environment: Next Steps

Speaker: Dr. Georges France, Region Head Quality Europe, Novartis

11.30 – 12.20

Definition of Starting Materials for the Synthesis of the Active Substance – the EMA View

Speakers: Dr. Ron Ogilvie, Pfizer
Dr. Robert Bream, Scientific Administrator, Quality, EMA

12.20 – 13.20 Lunch
13.20 – 14.00

Concepts of Quality by Design for Analytical Methods and Opportunities for Post Approval Change Management

Speaker: Dr. Oliver Grosche, Governance & Regulations Lead, Novartis

14.00 – 14.40

Quality Efficiency by Design - A Holistic Operator Centric Approach to OPTIMISE Operational Quality Systems and AVOID Human Errors

Speakers: Xavier Duburcq, Group BD Director, Altran
Olivier Depardieu , Consulting Partner, Oxo Pharma

14.40 – 15.10 Networking Break
15.10 – 15.50

Round Table

Moderator: Dr. Georges France, Region Head Quality Europe, Novartis

15.50 Closing Remarks

Track 2: QRM

Theme 2: QRM in the Supply Chain / Managing Shortages
07.50 – 08.30

Morning Coffee

08.30 – 09.10

Drug Shortages: Update on Regulators and Industry Associations View

Speaker: Dr. John Berridge, Strategic Advisor, ISPE

09.10 – 09.30

Regulatory Update on Initiatives to Avoid Shortages

Speaker: Dr. Brendan Cuddy, Scientific Administrator, EMA

09.30 – 09.50

A Risk-based Approach Addressing Shortages

Speaker: Emma Ramnarine, Senior Director, Head Global Biologics QC Network, Genentech Roche/PDA Task Force Leader for TR54 QRM and TR54 Annex 4 Drug Shortages, PDA

09.50 – 10.20 Networking Break
10.20 – 10.45

Drug Shortages and Communications

Speaker: Birgitte Holst, Director, Novo Nordisk/Member of Technical Development and Operations Committee, EFPIA

10.45 – 11.00

The PPTA Shortage Project

Speaker: John Delacourt, Vice President, Legal Affairs, Plasma Protein Therapeutics Association (PPTA)

11.00 – 11.40

QRM and Shortages Globally, and in the EU

Speaker: David Mark Churchward, Expert GMDP Inspector, MHRA

11.40 – 12.20

Good Distribution Practice - Industry Perspective of Application of Quality Risk Management in a Global Supply Chain

Speaker:  Simon White, Regional Leader, Quality Operations,  Pfizer

12.20 – 13.20 Lunch
13.20 – 14.00

The Roles of Quality Culture and Regulatory Relationships in Preventing Shortages
Industry-Regulatory Roundtable

Moderator: Bryan Wright, European Regulatory Advisor, ISPE
Panellists: Speaker Line-Up from QRM in the Supply Chain / Managing Shortages

Theme 3: Experiences of QRM
14.00 – 14.40

Tackling the Hottest Topics in Process Validation

Speaker: Wendy Zwolenski-Lambert, Global Validation Leader, Technical Operations, Novartis

14.40 – 15.10 Networking Break
15.10 – 15.40

Cross Contamination and QRM – EC GMP Guide Chapter 3 and 5, “Tox Tool”

Speaker: Dr. Thomas Pfister, Roche

15.40 – 16.10

New Method for the Implementation of a Process-Risk Analysis

Speakers: Dr. Jan Peter Spengler, Head of Quality Assurance Operations and Lead Qualified Person, and Hanno Juhnke, Head of Manufacturing, Sanofi, Frankfurt

16.10 – 16.30

Panel Discussion - Improving the QRM Approach

Moderator: Bryan Wright, European Regulatory Advisor, ISPE
Panellists: Speaker line-up from Experiences of QRM

Track 3: Facilities of the Future

Theme 2: Facilities for Biopharmaceuticals in the Future
07.50 – 08.30

Morning Coffee

08.30 – 09.10

Overview of the New ISPE Biopharmaceutical Facility Guide

Speaker: Mark von Stwolinski RA, Associate, Vice President Facility Integration, CRB

09.10 – 09.50

Continuous Processing in Biotech Production

Speaker: Dr. Thomas Daszkowski, VP Process Development and Optimisation, Bayer Technology Services

09.50 – 10.20 Networking Break
10.20 – 11.00

EMA Observations and Recommendations for Future Facilities - Including EU GMP to Avoid Cross Contamination

Speaker: Dr. Brendan Cuddy, Scientific Administrator, EMA

11.00 – 11.40

FDA Observations and Recommendations for Future Facilities - The Difficult Intersection of Pharmaceutical Quality and Drug Shortages (Robust Aseptic Processing)

Speaker: Dara Corrigan, Director, Europe Office, FDA

Theme 3: Operational Excellence and Compliance in the Future
11.40 – 12.20

Merck: Building for Lean High Performance

Speaker: Sarah Fitzgerald, Associate Director, Global Eng Svcs, Merck

12.20 – 13.20 Lunch
13.20 – 14.00

Enterprise Compliance Management (ECOM) Based on Integrated Data Management

Speakers: Dr. Gabriele Schoenberger, Boehringer Ingelheim
Dr. Tobias Salb, Location Manager Freiburg, Trivadis GmbH

14.00 – 14.40

Building Quality into a New Approach to Portable, Continuous and Miniature Manufacturing

Speaker: Brian Henry, Executive Director, Head of Drug Product Design, Pfizer

14.40 – 15.10 Networking Break
15.10 – 15.40

Future Facilities for Biopharmaceutical Processing

Speaker: Niels Guldager, Senior Technology Partner, NNE Pharmaplan

15.40 – 16.20

Flexible and Highly Efficient – Future Manufacturing of Small Batch Parenterals

Speaker: Dr. Johannes Rauschnabel, Engineering Pharma Processing, Bosch

16.20 – 16.30 Next Steps & Closing Remarks

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