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Conference Programme

Tuesday, 5 May 2015
07.00 – 08.30 Speaker Breakfast and Speaker Update
08.00 – 08.30 New Member/First Time Attendee Orientation Breakfast (Room: Universum)
08.00 – 08.30 Welcome Coffee (Exhibit Hall)
08.30 – 08.35

Opening of the Conference

Chair: Jean-Francois Duliere, Technip Life Sciences

08.35 – 08.55 Welcome Address and Presenting the Regulatory System in Germany

Speakers: Klaus Eichmueller, Darmstadt/Regierungspraesidium
John Bournas, CEO, ISPE

Plenary Sessions
08.55 – 09.30

Innovation in Biologics Manufacturing

Speaker: Hitto Kaufmann, Sanofi

09.30 – 10.25

Quality Culture: A Transformative Force in Pharmaceutical Operations

Speaker: Dr. Mary Oates, Pfizer

10.25 – 11.00

Networking Break (Exhibit Hall)

11.00 – 11.40

Regulatory Compliance – Data Management Matters!

Speaker: Robert Nass, Merck Millipore

11.40 – 12.10

Global Supply – An EMA Perspective

Speaker: Brendan Cuddy, EMA

12.10 – 13.40 Lunch (Exhibit Hall)
Track 1: Managing Quality under the New Paradigm
13.40 – 14.20

Lifecycle CMC Management – The ICH Q12 Concept Paper and Its Objectives

Speaker: Dr. Jean-Louis Robert, LNS

14.20 – 15.00

The Role of Process Knowledge and Controls in Managing Change

Speaker: Dr. Julie Ennis, AstraZeneca

15.00 – 15.40

Networking Break (Exhibit Hall)

15.40 – 16.20

How the CMC Submission Supports Lifecycle Management

Speaker: Dr. Roger Nosal, Pfizer

16.20 – 17.00

How the CMC Submission Supports Lifecycle Management

Speaker: Dr. Evdokia Korakianiti, EMA

17.00 – 18.00

Networking Drink (Exhibit Hall)

19.00 – 22.00

Networking Tour and Dinner

Track 2: Regulatory Trends and Drug Shortages in Europe and Beyond
Theme 1:GMP Harmonisation
13.40 – 14.20

Regulatory Harmonisation – Global and EU Perspective

Speaker: Mark Birse, MHRA

Regulatory Harmonisation – Industry Perspective

Speaker: Andy Tudor, Pfizer

14.20 – 15.00

Regulatory Changes – Past and Present

Speaker: Mark Birse, MHRA

15.00 – 15.40

Networking Break (Exhibit Hall)

15.40 – 16.10

GMP Data Integrity and Inspection Guidelines

Speaker: David Churchward, MHRA

16.10 – 16.40

Practical Implications in Applying Regulations and Guidelines on the Design and Validation of an Automatic Machine for Pharmaceutical Production

Speaker: Dr. Marco Bellentani, MG2 S.r.l 

16.40 – 17.10

Risk Management and Integrated Quality in the Supply Chain - How to Prevent Effectively Drug Shortages?

Speaker: Dr. Annette Schoenleben-Janas, Boehringer Ingehlheim 

17.00 – 18.00

Networking Drink (Exhibit Hall)

19.00 – 22.00

Networking Tour and Dinner

Track 3: Facilities of the Future: Achieving Cost-Effective Manufacturing Flexibility
Theme 1: Continuous Manufacturing
13.40 – 14.20

Getting the Benefits of LEAN Manufacturing in Pharmaceutical Manufacturing 

Speaker: Lars Bang, H. Lundbeck A/S

14.20 – 15.00

Continuous Manufacturing – An Industry Perspective and Inherent Quality Aspects
Product Controls Description with QbD

Speaker: Markus Krumme, Novartis

15.00 – 15.40

Networking Break (Exhibit Hall)

15.40 – 16.20

A Concept for the Biofacility of the Future 

Speaker: Stefan Sievers, Bayer Technology Services

16.20 – 17.00

MES and the Pharma Shop Floor Operations of the Future 

Speaker: Marc Bayer, Werum IT Solutions GmbH

17.00 – 18.00

Networking Drink (Exhibit Hall)

19.00 – 22.00

Networking Tour and Dinner

Track 4: IT Innovation for Effective Business Solutions and Regulatory Compliance
Theme 1: Serialisation
13.40 – 14.20

Serialisation, Regulatory Landscape
A comparison of global regulatory requirements and the implications for a harmonised solution

Speaker: Peter Iles-Smith, GSK

14.20 – 15.00

The Challenge of Pharma Serialisation, Example EU-FMD and EFPIA’s European Stakeholder Model

Speaker: Christoph Kraehenbuehl, 3C Integrity Consulting Ltd.

15.00 – 15.40

Networking Break (Exhibit Hall)

15.40 – 16.20

Case Study: Mass Serialisation and Track & Trace Implementation

Speaker: Fatma Taman, Pharmavision

16.20 – 17.00

Serialisation: About More Than Compliance

Speaker: Yvonne Sargent, ESP Ireland

17.00 – 18.00

Networking Drink (Exhibit Hall)

19.00 – 22.00

Networking Tour and Dinner

Wednesday, 6 May 2015
Track 1: Managing Quality under the New Paradigm
08.00 – 08.30 Welcome Coffee (Exhibit Hall)
08.30 – 09.10

Role of Quality System in Quality Assurance and Change Management

Speaker: Dr. David Tainsh, GSK

09.10 – 09.50

Role of Quality System in Quality Assurance and Change Management, Part 2

Speakers: Ian Thrussel, WHO

09.50 – 10.30

Networking Break (Exhibit Hall)

10.30 – 11.10

Role of Quality System in Quality Assurance and Change Management, Part 3

Speaker: TBC

11.10 – 11.50

Panel Discussion 

Moderated by Ron Olgivie, Pfizer

Participants:
Ian Thrussell, WHO
David Tainsh,GSK
Jean-Louis Robert, LNS

11.50 – 13.20

Lunch (Exhibit Hall)

13.20 – 14.00

Knowledge Management

Speaker: Ursula Busse, Novartis

14.00 – 14.40

The Discretion of a Qualified Person

Speaker: James Muller, Pfizer

14.40 – 15.10

Networking Break (Exhibit Hall)

15.10 – 15.50

QbD in Pharmaceutical Production – Curse or Blessing? 
Sharing Successes and Lessons Learned

Speaker: Lorenz Liesum, Novartis

15.50  – 16.30

Quality Culture

Speaker: Claudia Sigg, Boehringer Ingehlheim

16.30

Closing Remarks

Track 2: Regulatory Trends and Drug Shortages in Europe and Beyond
Theme 2: Shortages and a Harmonised Approach
08.00 – 08.30 Welcome Coffee (Exhibit Hall)
08.30 – 09.00

Drug Shortages in Europe

Speaker: Brendan Cuddy, EMA

09.00 – 09.10

The Inter-Association Task Force: An Overview

Speaker: John Berridge, ISPE

09.10 – 09.30

Risk Based Approach to Preventing and Managing Drug Shortages – A Product Specific Approach

Speaker: Georg Roessling, PDA 

09.30 – 09.50

Mitigating Drug Shortage Prevention Plan – Ensuring Business Continuity

Speaker: Sam Venugopal, PwC

09.50 – 10.30

Networking Break (Exhibit Hall)

10.30 – 10.50

Communications with Authorities

Speakers: Koen Nauwelaerts, EGA
Par Tellner, EFPIA

10.50 – 11.10

A NCA Perspective

Speaker: Simeon Gill, MHRA

11.10 – 11.30

Shortage Preparedness: A Case Study

Speaker: John Delacourt, PPTA

11.30 – 11.50

Drug Shortages – Discussion on Next Steps

Moderated by John Berridge

11.50 – 13.20

Lunch (Exhibit Hall)

Theme 3: Harmonisation and Recent Legislative Changes to EU GMP
13.20 – 14.00

Cleaning Validation – A Harmonised Approach 

Speaker: Andrew Hopkins, MHRA

14.00 – 14.40

Case Study: Process Validation Lifecycle Approach on a Biomolecule Drug Product

Speaker: Gary Gamboa, Eli Lilly

14.40 – 15.10

Networking Break (Exhibit Hall)

15.10 – 16.30

Proposed Changes to EUGMP Annex 1 – Potential New Requirements

- MHRA Perspective
Speaker: Andrew Hopkins, MHRA

- ISPE Perspective
Speaker: Charlotte Enghave Fruergaard, ISPE

- A3P Perspective
Speakers: Roland Guinet, A3P
Jean-Francois Duliere, Technip Life Sciences

16.30

Closure

Track 3: Facilities of the Future: Achieving Cost-Effective Manufacturing Flexibility
Theme 2: Flexibility
08.00 – 08.30 Welcome Coffee (Exhibit Hall)
08.30 – 09.10

Impact on Human Resources of the Technologies of the Factory of the Future

Speaker: Ramon Antelo, Altran

09.10 – 09.50

Flexible Manufacturing of Cell Therapy Product, Challenges and Possible Solutions

Speaker: Nadav Eshkol, Pluristem Therapeutics

09.50 – 10.30

Networking Break (Exhibit Hall)

10.30 – 11.10

Flexibility and Serialisation: Is It Compatible, And How to Manage It?

Speaker: Matthieu Thibaud, Abbott Products Organics AG

Theme 3: Operational Excellence
11.10 – 11.50

New Updated ISPE OSD Baseline Guide 3rd Edition for Facilities of the Future 

Speaker: Richard Denk, SKAN and ISPE

11.50 – 13.20

Lunch (Exhibit Hall)

13.20 – 14.00

FDA’s 2011 Process Validation Guidance: A Blueprint for Modern Pharmaceutical Manufacturing 

Speaker: John Hyde, Hyde Engineering and Consulting

14.00 – 14.40

Quality Metrics

Speakers: Lorraine Thompson, Novartis
Mairead Goetz, Novartis
Vanya Telpis, McKinsey & Company

14.40 – 15.10

Networking Break (Exhibit Hall)

15.10 – 15.50

Rapid/Automated Environmental Monitoring on the Manufacturing Floor

Speaker: Lindsey Colvin, Pfizer

15.50 – 16.30

Process and Quality Challenge for SuS

Moderator: Malik Belattar, Pharma Biot’Expert

Presenters: Alain Pralong, GSK 
Malik Belattar, Pharma Biot’Expert
Mathieu Tricot, Pharma Biot’Expert

Roundtable Participants:
Helene Pora
Carole Langlois, Sartorius
Niels Guldager, NNE Pharmaplan

16.30

Closing Remarks

Track 4: IT Innovation for Effective Business Solutions and Regulatory Compliance
Theme 2: Operational Excellence
08.00 – 08.30 Welcome Coffee (Exhibit Hall)
08.30 – 09.10

Avoiding the Pain of ERP Implementations

Speaker: Chris Reid, Integrity Solutions Limited

09.10 – 09.50

Are You Ready to Implement an EDMS?

Speaker: Keith Williams, GxPi

09.50 – 10.30

Networking Break (Exhibit Hall)

10.30 – 11.10

Plant-IT-Automation Concepts for a Zero-Defects Manufacturing in Pharma and Faster New Product Introduction

Speaker: Ivo Backx, Siemens

Theme 3: Integrated Information Management and Data Integrity
11.10 – 11.50

Overcoming the Challenges of an Integrated IM Strategy

Speaker: Sam Brooks, Brooks I3 Ltd.

11.50 – 13.20

Lunch (Exhibit Hall)

13.20 – 14.00

Auditing for Data Integrity Issues

Speaker: Chris Clark, TenTenTen Consulting

14.00 – 14.40

Data Flow in Clinical Trials and Systems

Speaker: Frank Henrichmann, PAREXEL

14.40 – 15.10

Networking Break (Exhibit Hall)

15.10 – 15.50

Protecting Your Operations from Cyber Security Threats

Speaker: Konrads Smelkovs, KPMG

15.50 – 16.30

Managing Data Quality Threats during Product Development

Speaker: Oliver Hermann, Q-FINITY

16.30

Closure

Thursday, 7 May 2015
Optional Plant Tours
Sanofi Frankfurt
09.00 Tour departure (meeting point in the hotel lobby)
09.30 – 09.45

Welcome and registration

All participants have to provide their ID numbers in advance and have their IDs with them during the tour and to access.

09.45 – 10.00

Ride to the Insulin plant (MIB)

10.00 – 11.00

Plant tour

Visit of the Insulin plant (MIB)

+/- 11.00

Departure back to the hotel

Lufthansa Cargo Centre
08.30

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

09.00 – 09.30

Plant tour

Visit of the Lufthansa Cargo Cool Center (LCCC)

+/- 09.30

Departure back to the hotel