Programme
Day 1: 4 May 2015
EXECUTIVE FORUM – Dr. Thomas Zimmer, VP European Operations, ISPE
13:00 – 13:20
Opening of the Executive Forum
Introduction and Welcome by the Chairman of the Conference
Dr. Thomas Zimmer, VP European Operations, ISPE
13:20 – 14:20
Political and Economic Situation in Pharmaceutical Industry in Europe
Professor Dr. Manfred Schubert-Zsilavecz, Institute of Pharmaceutical Chemistry, University of Frankfurt
14:20 – 15:00
BEMA: Benchmarking for Medicines Regulators
Dr. Caitriona Fisher, Health Products Regulatory Authority, BEMA
15:00 – 15:30
15:30 – 16:20
NETWORKING BREAK (Exhibit Hall)
There Can Be Only One: An Integrated Quality and Production System
Paul Rutten, McKinsey& Company
Wolf-Christian Gerstner, McKinsey & Company
16:20 – 17:00
How the Pharmaceutical Industry Can Benefit from the Automotive Sector
Dirk Pfitzer, Porsche Consulting
17:00 – 17:40
Quality as an Enabler, at Nestlé Health Science
Jean-Marc Heintz, Nestlé Health Science
17:40 – 18:10
WHO Prequalification (Vaccine Assessment Requirements)
Dr. Andrew Meek, WHO
18:10
Closure
19:10
DINNER (Unterschweinstiege Restaurant)
2
Day 2: 5 May 2015
PLENARY SESSION – Jean-Francois Duliere, Technip Life Sciences
07:00 –08:30
SPEAKER BREAKFAST AND SPEAKER UPDATE
08:00 –08:30
NEW MEMBER/FIRST TIME ATTENDEE ORIENTATION BREAKFAST (Room: Universum)
WELCOME COFFEE (Exhibit Hall)
Opening of the Conference
Chair: Jean-Francois Duliere, Technip Life Sciences
08:00 –08:30
08:30 –08:55
Welcome Address and Presenting the Regulatory System in Germany
Klaus Eichmueller, Darmstadt/Regierungspraesidium
John Bournas, CEO, ISPE
08:55–09:30
Innovation in Biologics Manufacturing
Hitto Kaufmann, Sanofi
9:30 –10:25
Quality Culture: A Transformative Force in Pharmaceutical Operations
Dr. Mary Oates, Pfizer
10:25 –11:00
NETWORKING BREAK (Exhibit Hall)
Regulatory Compliance – Data Management Matters!
Robert Nass, Merck Millipore
11:00 –11:40
11:40 –12:10
Global Supply – An EMA Perspective
Brendan Cuddy, EMA
12:10 –13:40
LUNCH (Exhibit Hall)
3
PARALLEL TRACKS
Universum
Track 3: Facilities of the Future: Achieving CostEffective, Manufacturing, Flexibility
Track Leaders: Jean-Francois Duliere and Gert
Moelgaard
Salon 9
Salon 10
14:20 – 15:00
14:20 – 15:00
The Role of Process Knowledge
and Controls in Managing
Change
15:00 – 15:40
Dr. Julie Ennis, AstraZeneca
Regulatory Harmonisation –
Industry Perspective
Andy Tudor, Pfizer
Regulatory Changes – Past and
Present
Mark Birse, MHRA
14:20 – 15:00
13:40 – 14:20
13:40 – 14:20
Dr. Jean-Louis Robert, LNS
Regulatory Harmonisation –
Global and EU Perspective
Mark Birse, MHRA
Salons 1-4
Theme 1: Continuous Manufacturing
13:40 – 14:20
Theme 1:GMP Harmonisation
Lifecycle CMC Management –
The ICH Q12 Concept Paper and
Its Objectives
Track 4: IT Innovation for Effective Business
Solutions and Regulatory Compliance
Track Leaders: Chris Reid and Jens Seest
Getting the Benefits of LEAN
Manufacturing in Pharmaceutical
Manufacturing
Lars Bang, H. Lundbeck A/S
Continuous Manufacturing – An
Industry Perspective and Inherent
Quality Aspects
Product Controls Description with QbD
Markus Krumme, Novartis
Theme 1: Serialisation
13:40 – 14:20
Track 2: Regulatory Trends and Drug
Shortages in Europe and Beyond
Track Leaders: Bryan Wright and Buket
Hekiman
Serialisation, Regulatory Landscape
A comparison of global regulatory
requirements and the implications for a
harmonised solution
Peter Iles-Smith, GSK
14:20 – 15:00
Track 1: Managing Quality under the New
Paradigm
Track Leaders: Georges France and Ron Ogilvie
The Challenge of Pharma Serialisation,
Example EU-FMD and EFPIA’s European
Stakeholder Model
Christoph Kraehenbuehl, 3C Integrity
Consulting Ltd.
Dr. Evdokia Korakianiti, EMA
Practical Implications in Applying
Regulations and Guidelines on the
Design and Validation of an
Automatic Machine for
Pharmaceutical Production
Dr. Marco Bellentani, MG2 S.r.l.
4
Stefan Sievers, Bayer Technology
Services
MES and the Pharma Shop Floor
Operations of the Future
Marc Bayer, Werum IT Solutions GmbH
15:40 – 16:20
15:40 – 16:20
David Churchward, MHRA
A Concept for the Biofacility of the
Future
16:20 – 17:00
16:20 – 17:00
How the CMC Submission
Supports Lifecycle Management
GMP Data Integrity and Inspection
Guidelines
16:20 – 17:00
Dr. Roger Nosal, Pfizer
16:10 – 16:40
15:40 – 16:20
How the CMC Submission
Supports Lifecycle Management
15:40 – 16:10
NETWORKING BREAK (Exhibit Hall)
Case Study: Mass Serialisation and
Track & Trace Implementation
Fatma Taman, Pharmavision
Serialisation: About More Than
Compliance
Yvonne Sargent, ESP Ireland
17:00 – 18:00
Dr. Annette Schoenleben-Janas,
Boehringer Ingehlheim
NETWORKING DRINK (Exhibit Hall)
19:00 – 22:00
16:40 – 17:10
Risk Management and Integrated
Quality in the Supply Chain – How
to Prevent Effectively Drug
Shortages?
NETWORKING TOUR AND DINNER (Hofgut Laubenheimer Höhe Restaurant – Buses departing at 18:30 from the hotel lobby)
5
Day 3: 6 May 2015
Track 1: Managing Quality under the New
Paradigm
Chairs: Georges France and Ron Ogilvie
Track 3: Facilities of the Future: Achieving CostEffective, Manufacturing, Flexibility
Chairs: Jean-Francois Duliere and Gert Moelgaard
Salon 9
Theme 2: Shortages and a Harmonised
Approach
Track 4: IT Innovation for Effective Business Solutions
and Regulatory Compliance
Chairs: Chris Reid and Jens Seest
Salon 10
Salons 1-4
Theme 2: Flexibility
Them 2: Operational Excellence
WELCOME COFFEE (Exhibit Hall)
09:30 – 9:50
09:10 – 9:30
09:10 – 09:50
Ian Thrussel, WHO
6
Ramon Antelo, Altran
Avoiding the Pain of ERP Implementations
08:30 – 9:10
08:30 – 9:10
The Inter-Association Task Force: An
Overview
Impact on Human Resources of the
Technologies of the Factory of the Future
Are You Ready to Implement an EDMS?
John Berridge, ISPE
Keith Williams, GxPi
Nadav Eshkol, Pluristem Therapeutics
Risk Based Approach to Preventing
and Managing Drug Shortages – A
Product Specific Approach
Georg Roessling, PDA
Mitigating Drug Shortage Prevention
Plan – Ensuring Business Continuity
Sam Venugopal, PWC
Chris Reid, Integrity Solutions Limited
Flexible Manufacturing of Cell Therapy
Product, Challenges and Possible Solutions
09:10 – 09:50
Role of Quality System in Quality
Assurance and Change
Management II
Brendan Cuddy, EMA
09:10 – 09:50
Dr. David Tainsh, GSK
Drug Shortages in Europe
08:30 – 9:00
Role of Quality System in QA and
Change Management
09:00 – 9:10
08:30 – 9:10
08:00 – 08:30
Universum
Track 2: Regulatory Trends and Drug
Shortages in Europe and Beyond
Chairs: Bryan Wright and Buket Hekiman
TBC
A NCA perspective
Matthieu Thibaud, Abbott Products
Operations AG
John Delacourt, PPTA
Drug Shortages – Discussion on Next
Steps
Richard Denk, SKAN and ISPE
11:10 – 11:50
11:10 – 11:30
Overcoming the Challenges of an Integrated
IM Strategy
Sam Brooks, Brooks I3 Ltd.
Moderated by John Berridge
LUNCH (Exhibit Hall)
7
13:20 – 14:00
Ursula Busse, Novartis
Theme 3: Harmonisation and Recent
Legislative Changes to EU GMP
Cleaning Validation – A Harmonised
Approach
Andrew Hopkins, MHRA
FDA’s 2011 Process Validation Guidance: A
Blueprint for Modern Pharmaceutical
Manufacturing
John Hyde, Hyde Engineering and Consulting
Auditing for Data Integrity Issues
13:20 – 14:00
Knowledge Management
13:20 – 14:00
Theme 3: Integrated Information Management and
Data Integrity
New Updated ISPE OSD Baseline Guide 3rd
Edition for Facilities of the Future
11:10 – 11:50
Jean-Louis Robert, LNS
11:30 – 11:50
Participants:
Ian Thrussell, WHO
David Tainsh,GSK
Shortage Preparedness: A Case Study
13:20 – 14:00
11:50 – 13:20
11:10 – 11:50
Moderated by Ron Olgivie, Pfizer
Ivo Backx, Siemens
Simeon Gill, MHRA
Theme 3: Operation Excellence
Panel Discussion
Plant-IT-Automation Concepts for a ZeroDefects Manufacturing in Pharma and Faster
New Product Introduction
10:30 – 11:10
Koen Nauwelaerts, EGA
Par Tellner, EFPIA
Flexibility and Serialisation: Is It Compatible,
and How to Manage It?
10:30 – 11:10
Communications with Authorities
10:50
11:10
10:30 – 11:10
Role of Quality System in Quality
Assurance and Change
Management III
10:30
10:50
09:50 – 10:30
NETWORKING BREAK (Exhibit Hall)
Chris Clark, TenTenTen Consulting
Gary Gamboa, Eli Lilly
Quality Metrics
Lorraine Thompson, Novartis
Mairead Goetz, Novartis
Vanya Telpis, McKinsey & Company
14:00 – 14:40
Case Study: Process Validation
Lifecycle Approach on a Biomolecule
Drug Product
14:00 – 14:40
14:00 – 14:40
James Muller, Pfizer
Data Flow in Clinical Trials and Systems
Frank Henrichmann, PAREXEL
Lorenz Liesum, Novartis
- ISPE Perspective
Charlotte Enghave Fruergaard, ISPE
Quality Culture
15:50 – 16:30
15:50 – 16:30
Claudia Sigg, Boehringer Ingelheim
- A3P Perspective
Dr. Roland Guinet, A3P
Jean-Francois Duliere, Technip Life
Sciences
Lindsey Colvin, Pfizer
Moderator: Malik Belattar, Pharma
Biot’Expert
Presenters: Alain Pralong, GSK, Malik
Belattar, Pharma Biot‘Expert and Matthieu
Tricot, Pharma Biot’Expert
8
Protecting Your Operations from Cyber
Security Threats
Konrads Smelkovs, Cyber Defence Services,
KPMG
Managing Data Quality Threats during
Product Development:
Process and Quality Challenge for SuS
Roundtable Participants:
Helene Pora
Carole Langlois, Sartorius
Niels Guldager, NNE Pharmaplan
Closure
15:10 – 15:50
- MHRA Perspective
Andrew Hopkins, MHRA
Rapid/Automated Environmental
Monitoring on the Manufacturing Floor
Oliver Hermann, Q-FINITY
15:50 – 16:30
Proposed Changes to EUGMP Annex
1 – Potential New Requirements
15:50 – 16:30
QbD in Pharmaceutical Production
– Curse or Blessing?
Sharing Successes and Lessons
Learned
15:10 – 15:50
NETWORKING BREAK (Exhibit Hall)
15:10 – 15:50
14:00 – 14:40
14:40
15:10
15:10 – 15:50
The Discretion of a Qualified
Person
OPTIONAL PLANT TOURS
Day 4: 7 May
Sanofi Multi-Insulin-Facility
Frankfurt
Lufthansa Cargo Centre
Frankfurt
Tour departure (meeting point in the hotel lobby)
+/- 11:00
10:00 – 11:00
9
08:30
All participants have to provide their ID numbers in advance and
have their IDs with them during the tour and to access.
Ride to the Insulin plant (MIB)
Plant tour
Visit of the Insulin plant (MIB)
Departure back to the hotel
09:00 – 09:30
Welcome and registration
+/- 09:30
09:45 – 10:00
9:30 – 09:45
09:00
Tour departure (meeting point in the hotel lobby)
All participants have to provide their ID numbers in advance and have their IDs with them
during the tour and to access.
Plant tour
Visit of the Lufthansa Cargo Cool Center (LCCC)
Departure back to the hotel