“A major challenge and opportunity for health regulators, academia and pharmaceutical industry”
Saturday 6 September 2008
at the Kervansaray Hotel, Antalya, Turkey HALL A
A one-day workshop organised as pre-satellite to the International Pharmaceutical Technology Symposium
Moderators: Dr Mansoor Khan (US FDA), Dr Tom Sam (FIP)
Co-sponsored by
FIP’s Industrial Pharmacy Section
CALL FOR PARTICIPATION
The aims of the Quality by Design workshop are: 1.to give a concise overview of current ICH and regional guidelines on Pharmaceutical Development, Process Analytical Technology and Quality Risk Management
2.to present examples of implementation
The format of the Quality by Design workshop is:
· Plenary presentations by leading international experts
· For each session case studies showing real-life examples
· Panel discussion at the end of the day
Goal of the workshop:
With the advent of Quality by Design, pharmaceutical companies are implementing science and risk based approaches. From a regulatory point of view these approaches are backed by the new ICH Q8 guideline on Pharmaceutical Development, the new ICH Q9 guideline on Quality Risk Management and the ICH Q10 guideline on Pharmaceutical Quality Systems. Moreover regional guidelines exist providing guidance on Process Analytical Technology practices. This new quality thinking will substantially influence daily practice, procedures and processes for regulators and industry. Academics teaching Pharmaceutical Technology need to understand the implications and revamp their curriculum as needed.
The goal of this conference is to provide the participants in just one day with understanding of the concept of quality by design, allowing them to communicate on quality by design with their stakeholders both inside and outside their department.
Dr Mansoor A. Khan is the Director of Product Quality Research at CDER in FDA. Prior to joining FDA, Dr. Khan was a Professor of Pharmaceutics and Director of Graduate Program in the School of Pharmacy at Texas Tech University Health Sciences Center. He also served as Assistant and then Associate Professor at the Northeast Louisiana University School of Pharmacy. He has earned his Ph.D. degree in Industrial Pharmacy from the St. John's University School of Pharmacy in 1992. He has published over 110 peer-reviewed manuscripts, four texts including the "Pharmaceutical and Clinical Calculations", five book chapters, and more than 100 presentations in various meetings. As a major advisor, Dr. Khan graduated 10 Ph.D.s, who are all employed by leading pharmaceutical industries, academia or FDA. Dr. Khan's research focus is primarily in the area of pharmaceutical technology, evaluation of critical formulation and process variables, drug delivery of challenging molecules, nanoparticles, and aqueous-based coating dispersions. He has held several leadership positions at the AAPS. Recently he was elected as the Vice Chair of PDD section, and selected as AAPS Fellow in 2005. He serves on the editorial board of Pharmaceutical Technology, and Journal of Clinical Research and Regulatory Affairs.
Dr. Tom Sam is Director Global Regulatory CMC, Organon, a part of Schering-Plough Corporation, the Netherlands. Previous functions included Director of Organon's Pharmaceutics Sections on Solid and Novel Dosage Forms. He is an expert in scientific and regulatory development of solid dosage forms and long-acting contraceptive systems, including vaginal and subdermal systems. He is member of Organon’s PAT working group and Quality Risk Management platform. Tom holds a Ph.D. from Leiden University and a Master degree in Business Management from Groningen University, the Netherlands. Tom Sam is
president of FIP's Industrial Pharmacy Section (www.industrialpharmacy.org),
member of the WHO Expert Committee on Specifications of Pharmaceutical Preparations,
past-president of the Netherlands Society for Pharmaceutical Sciences,
organiser of the European Symposia on Controlled Drug Delivery,
member of the AAPS Regulatory Sciences Section and the AAPS Manufacturing, Engineering & Quality Focus Group,
co-organiser of the WHO/FIP Training Workshop on Pharmaceutical Development with focus on Pediatric Formulations, Mumbai India
Other speakers:
Dr Mahmut Tokaç
Prof. Dr. Levent Öner (Hacettepe University)
Dr Carlo Durrer (Head of Quality Management of the Sandoz Group, Gebze, Turkey. Before joining Sandoz, a member of Novartis Group, he worked for Roche in Switzerland, USA, China and Turkey.
The registration fee includes:
Hand-outs of all powerpoint presentations and relevant guidelines both as hard copy and on CD-ROM, coffee and tea during the breaks, lunch.
Moderators: Dr. Mansoor Khan (FDA), Dr. Tom Sam (FIP)
08:30
Registration and coffee
09:00
Welcome Address: Dr. Mahmut Tokaç, Turkish Health Authorities,TR
SESSION 1: PHARMACEUTICAL DEVELOPMENT AND RISK MANAGEMENT
09:15
The philosophy of Quality by Design – an introduction to the ICH Q8 guideline
Dr. Tom Sam (NL)
10:00
QbD experience and research needs from a regulatory science point of view
Dr. Mansoor A. Khan (USA)
11:00
Coffee Break
SESSION 2: EXPERIENCES WITH QBD AND PAT
11:30
Quality risk management and introduction to the ICH Q9 guideline
Dr. Tom Sam (NL)
12:30
Lunch Break
13:30
Novartis/FDA CRADA QbD Project – API and DP Case Studies
Mr. Marc Goeller (USA)
SESSION 3: IMPACT OF QBD IMPLEMENTATION
14:30
The implications of QbD for the Common Technical Document
Dr. Tom Sam (NL)
15:00
Coffee Break
15:30
The need to re-evaluate the academic curriculum on pharmaceutical technology
Dr. Levent Öner (TR)
16:00
Challenges of dossier assessment and facility inspection in the QbD era- the view from the Health Authorities
Representative from Health Authorities (Turkey)
16:30
Challenges of dossier assessment and facility inspection in the QbD era- the view from pharmaceutical industry
Dr. Carlo Durrer (TR)
17:00
Panel Discussion
Dr. Mahmut Tokaç, Prof. Dr. Levent Öner, Dr. Mansoor Khan, Dr. Carlo Durrer,
Representative from Turkish Health Authorities, Dr. Tom Sam, Mr. Marc Goeller
Dr Mansoor A. Khan is the Director of Product Quality Research at CDER in FDA. Prior to joining FDA, Dr. Khan was a Professor of Pharmaceutics and Director of Graduate Program in the School of Pharmacy at Texas Tech University Health Sciences Center. He also served as Assistant and then Associate Professor at the Northeast Louisiana University School of Pharmacy. He has earned his Ph.D. degree in Industrial Pharmacy from the St. John's University School of Pharmacy in 1992. He has published over 110 peer-reviewed manuscripts, four texts including the "Pharmaceutical and Clinical Calculations", five book chapters, and more than 100 presentations in various meetings. As a major advisor, Dr. Khan graduated 10 Ph.D.s, who are all employed by leading pharmaceutical industries, academia or FDA. Dr. Khan's research focus is primarily in the area of pharmaceutical technology, evaluation of critical formulation and process variables, drug delivery of challenging molecules, nanoparticles, and aqueous-based coating dispersions. He has held several leadership positions at the AAPS. Recently he was elected as the Vice Chair of PDD section, and selected as AAPS Fellow in 2005. He serves on the editorial board of Pharmaceutical Technology, and Journal of Clinical Research and Regulatory Affairs.
Dr. Tom Sam is Director Global Regulatory CMC, Organon, a part of Schering-Plough Corporation, the Netherlands. Previous functions included Director of Organon's Pharmaceutics Sections on Solid and Novel Dosage Forms. He is an expert in scientific and regulatory development of solid dosage forms and long-acting contraceptive systems, including vaginal and subdermal systems. He is member of Organon’s PAT working group and Quality Risk Management platform. Tom holds a Ph.D. from Leiden University and a Master degree in Business Management from Groningen University, the Netherlands. Tom Sam is
