| |
|
|
|
RPSGB, London
26/11/07 - 27/11/07
MONDAY 26 NOVEMBER
Welcome Address: Dr Tom Sam, FIP
Session 1: Critical Process steps and critical parameters
Moderators: Dr Susanne Keitel (BfArM) and Dr Tom Sam (FIP)
Criticality – setting the scene
Dr Tom Sam, Director Global Regulatory Affairs, NV Organon, Netherlands
Critical Quality Attributes and Quality by Design
Dr Mark Kontny, Divisional VP Global Pharmaceutical and Analytical Sciences, Abbott
Laboratories, North Chicago
Panel discussion
Session 2: Critical Process steps in API manufacture
Moderator: Prof. Dr Peter York, Physical Pharmaceutics,
University of Bradford (EUFEPS), UK
Quality risk analyses to identify critical parameters and assess the robustness
of chemical manufacturing
Dr Thomas Allmendinger, Group Leader Process R&D, Novartis, Basel
Analysis of critical process parameters and risk mitigation strategies
in API manufacture
Dr Subodh Deshmukh, Associate Director Chemical Engineering Technology,
Wyeth Research, USA
Critical Process steps in API manufacture
Dr Christopher Brook, Head of Strategic Technologies, GlaxoSmithKline, USA
Panel discussion
Lunch buffet and Poster session 1
Session 3: Critical Process steps in biological manufacture
Moderators: Dr Howard Levine, Bioprocess Technology Consultants Inc. Biotechnology, USA
Dr Siddharth Advant, Director, Project Management, Diosynth, USA
Critical Factors to Consider when Implementing Quality
by Design for Biopharmaceuticals
Dr Alex Kanarek, AK Consulting Services, Canada
The Use of Critical Process Analysis to Reduce Risk and Increase
Monoclonal Antibody Product Quality
Dr Howard Levine, BioProcess Technology Consultants, Inc., Acton, MA, USA
Challenges in the identifi cation of critical parameters for biotechnology processes
Dr Siddharth Advant, Director Project Management, Diosynth Biotechnology, USA
Panel discussion
Session 4: Critical Process steps in tablet manufacture/ dry mixing
Moderators: Mukund ‘Mike’ Yelvigi, Barends (RIVM)
Understanding Critical Process Parameters in Quality by Design -
tablet case study dry granulation method
Dr Mike Yelvigi, Director Development Planning, Wyeth Research Laboratories, USA
Tablet manufacturing through dry mixing – critical steps
Dr Kelly Canter, Head Business Development, Process & Performance, Right First Time,
Pfi zer, USA
Dry mixing, a low risk process (due to the knowledge gap?)
Dr Kaspar van den Dries, Group Leader Solids, Product Development Department,
NV Organon, the Netherlands
Panel discussion
Wine Reception and poster session 1
TUESDAY 27 NOVEMBER
Session 5: Critical Process steps in tablet manufacture/ wet granulation
Moderator: Mukund ‘Mike’ Yelvigi
Evaluation of critical process steps in wet granulation/tablet manufacturing processes
– development, scale-up and the use of prior knowledge
Dr Christian Seiler, Research Fellow, Merck Research Laboratories, Hoddesdon, UK
Wet granulation and critical process steps
Dr Alexander Glomme, Hoffman La Roche, Basel, Switzerland
Advanced Control Systems to Improve Effi ciency of Pharmaceutical Manufacturing
Processes, via PAT Measurement of Critical Quality Attributes
Dr Steve Hammond, Director Process Analytical Support Group, Pfi zer, USA
Panel discussion
Session 6: Critical Process steps in parenteral manufacture / aseptic fi lling
Moderator: Dr Moheb Nasr, Director Offi ce of New Drug Quality Assessment, FDA, USA
Risk analysis applied for evaluation of critical aspects in design, set up
and validation of aseptic powder fi lling
Dr Michael Jahnke, Wülfi ng Pharma GmbH, Quality Assurance, Gronau, Germany
Panel discussion
Session 7: Critical Process steps in parenteral manufacture / heat
and gamma sterilization
Moderator: Dr Moheb Nasr, Director Offi ce of New Drug Quality Assessment, FDA, USA
Heat Sterilization of parenteral products - Critical parameters
Prof. Terezinha Pinto, Faculty of Pharmaceutical Sciences, University of São Paulo, Brazil
Critical steps on Radiation Sterilization
Prof. Terezinha Pinto, Faculty of Pharmaceutical Sciences, University of São Paulo, Brazil
Panel discussion
Lunch buffet and Poster session 2
Session 8: Critical Process steps in freeze-drying
Moderator: Dr Mathew Cherian, Director Pharm. Dev. Services, Patheon, Italy
Critical Parameters in Freeze-Drying
Prof. Dr Louis Rey, Head of the Experimental Lyophilization Laboratory, Switzerland
Designing the critical process steps in Freeze Drying
Dr Mathew Cherian, Director Pharmaceutical Development Services, Patheon Italy
Summarizing presentation
Close of conference
|
|
|
|
|
|
|
|
Organized by:
|
|
Royal Pharmaceutical Society of Great Britain |
|
|
Invited Speakers:
|
|
LEARN FROM A TEAM OF INTERNATIONAL EXPERTS
Scientifi c Programme Committee
Tom Sam (chair, FIP), Mukund ‘Mike’ Yelvigi (Wyeth/AAPS), Mathew Cherian (FIP), Jayne Lawrence
(RPSGB), Vinod Shah (FIP), Susanne Keitel (EMEA), Staffan Folestad (EUFEPS), Bruce Davis
(ISPE)
Contributors
Dr Siddharth Advant, Director Project Management, Diosynth Biotechnology, USA
Dr Thomas Allmendinger, Group Leader Process R&D, Novartis, Basel
Dr Dirk Barends, National Institute for Public Health and the Enviroment, the Netherlands
Dr Christopher Brook, Head of Strategic Technologies, GlaxoSmithKline, USA
Dr Kelly Canter, Head Business Development, Process & Performance, Right First Time, Pfi zer,
USA
Dr Mathew Cherian, Director Pharmaceutical Development Services, Patheon, Italy
Dr Subodh Deshmukh, Associate Director Chemical Engineering Technology, Wyeth Research,
USA
Dr Kaspar van den Dries, Group Leader Solids, Product Development Department, NV Organon,
the Netherlands
Dr Alexander Glomme, Hoffman La Roche, Basel, Switzerland
Dr Steve Hammond, Director Process Analytical Support Group, Pfi zer
Dr Michael Jahnke, Wülfi ng Pharma GmbH, Quality Assurance, Gronau, Germany
Dr Alex Kanarek, AK Consulting Services, Canada
Dr Susanne Keitel, Federal Institute for Drugs and Medical Devices (BfArM), Germany
Dr Mark Kontny, VP Global Pharmaceutical and Analytical Sciences, Abbott Laboratories, USA
Dr Howard Levine, BioProcess Technology Consultants, Inc., Acton, USA
Dr Moheb Nasr, Director Offi ce of New Drug Quality Assessment, FDA
Prof. Dr Terezinha Pinto, Faculty of Pharmaceutical Sciences, University of São Paulo, Brazil
Prof. Dr Louis Rey, Head of the Experimental Lyophilization Laboratory, Switzerland
Dr Tom Sam, Director Global Regulatory Affairs, NV Organon, the Netherlands
Dr Christian Seiler, Research Fellow, Merck Research Laboratories, Hoddesdon, UK
Mukund ‘Mike’ Yelvigi, Director Development Planning, Wyeth Research Laboratories, USA
Prof. Dr Peter York, Physical Pharmaceutics, University of Bradford, UK
|
|
|
|
|
|
|
|
Deadline for Abstracts:
|
|
ASAP
|
|
|
|
|
|
|
|
Registration:
|
|
DELEGATE FEES
Delegate fees are £600 for members of RPSGB, FIP and the Academy of Pharmaceutical Sciences
and £630 for non-members. Fees are inclusive of lunches, refreshments, course documentation and
wine reception.
|
|
|
E-mail:
|
|
science@rpsgb.org
|
|
|
|
|
|
|
|
|