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Bio-International 2008: Towards improved harmonization in regulating multisource products

 
  May 23, 2008  
     
 
Royal Pharmaceutical Society of Great Britain, London, London
Wednesday 22 – Friday 24 October 2008


09:00    Welcome            Kamal K. Midha, FIP 
09:05
    Keynote address:
Advances in understanding and assessment of BE during the last two decades: Achievements and Gaps.  TBD 

Session 1: When are Clinical/Patient studies needed for Bioequivalence Assessment?
Moderators: Vinod P. Shah, FIP, USA and Lawrence Yu, FDA, USA
09:50    Cytotoxic drugs Rabi Patnaik, Watson Labs Inc., USA 
10:20
    An overview of BE of topical drugs: Where are we today?
Vinod P. Shah, FIP, USA 
10:50   Coffee break
 
11:10
    BE of Topical drugs: Clinical approaches
TBD
11:25    BE of Topical drugs: Alternative approaches Dennis Bashaw, FDA, USA 
11:40
   BE of Topical Drugs: Microdialysis and DPK
Eva Benfeldt, University of Copenhagen, Denmark 
12:00
   Q and A
 
12:30
   Lunch
 

Session 2: When are Clinical/Patient studies needed for Bioequivalence Assessment?
Moderators: Gur Jai Pal Singh, Watson Labs Inc., USA and T.S. Purewal, Bespak, UK
 
13:30
    Respiratory drugs – MDIs, DPIs
Gur Jai Pal Singh, Watson Labs Inc., USA
14:00   Scientific and Clinical Considerations in Evaluation of Bioequivalence of Respiratory Drugs Badrul Chowdhury, FDA, USA           
14:30
    Device and Formulations Considerations for Pharmaceutical Equivalence of Inhalation Drug Products
  T. S. Purewal, Bespak, UK
15:00    Coffee break 
15:30
   Formulation Development for Equivalent Performance of Dry Powder Inhalers
            Robert Price, University of Bath, UK
16:00    Q and A     

Session 3: International BE Issues and Assessments
Moderators: Mitsura Hashida, Kyoto University and Kamal K. Midha, FIP
 
16:30
   Evolving BE standards: Scientific challenges and regulatory opportunities
Lawrence Yu, FDA, USA 
17:00    India
Surinder Singh, DGI, India  
17:30    China
Sang Guowei, Chinese Pharmaceutical Association, China 

Welcome reception and networking  

Thursday 23 October 

Session 4:  International BE requirements and Comparator drug product
Moderators: Leon Shargel, Applied Biopharmaceutics, USA and Gordon Johnston, GPhA, USA
 
09:00
    Survey of International Bioequivalence Requirements
Henning Blume, Socratec, Germany
09:30    Maintaining the Quality of Multisource products around the world Lembit Rago, WHO, Switzerland
10:00    Use of an international reference listed drug product, RLD as a standard  Identify the problem Leon Shargel, USA
10:30    Coffee break
10:50    Drug product approval and maintenance of quality of multisource products in Brazil Renata A. Dias, Sindusfarma, Brazil. 
11:20
    Case study: Maintaining the quality of multisource products in India
Vinay Nayak, Watson Pharma Private Limited, India. 
11:50
    Q and A 

12:20
   Lunch
 

Session 5: Transdermal Drugs – BE Issues
Moderators: Rabi Patnaik, Watson Labs Inc., USA
 
13:20
    BE assessment of transdermal products – Current status and issues
Gordon Johnston, GPhA, USA  13:50    Formulation development and Transdermal absorption: Prediction of drug absorption by in vitro testing Scott Gochnour, Watson Labs Inc., USA  
14:20
    Challenges or strategies in dev eloping newer generations/types of generic  transdermal drug delivery systems
TBD 
14:50
    Coffee Break
 

Session 6: International Experience on BE Practice
Moderators: Kamal K. Midha, FIP and Gordon Johnston, GPhA, USA
 
15:10  Canada: Eric Ormsby, Therapeutic Products Directorate
Greece: Panos Macheras Turkey: Yilmaz Capan Jordan: Laila Jarra, Head of Drug Directorate Spain: TBD India: TBD   Korea: TBD  Hungary: Hilda Koszegi-Szalai 
18.00    Close of day
           

Friday 24 October 
09:00    Key note address:
Does the Interplay of efflux transporters and metabolic enzymes in the GI tract have any effect on BE determination? Les Benet, University of California, USA 

Session 7:  BCS Approach: Product Development
Moderators: Dirk Barends, National Institute for Public Health and the Environment, Netherlands and Mehul Mehta, FDA, USA

09:30    BCS approach in product development and assessment – Academic view point James Polli, University of Maryland, USA 
10:00
    BCS approach in product development and assessment – Industrial view point
Bertil Abrahamsson, AstraZeneca, UK
10:30    Break 
11:00
   BCS Approach in product development and assessment – Regulatory view point
            Mehul Mehta, FDA, USA 
11:30    Director of NICE
      
12:00
    Summary of sessions
           
Chair: Vinod P. Shah and Kamal K. Midha
 
12:45
   Q and A
 
13:45
    Closing remarks.
            Vinod P. Shah

 
 
Organized by: Royal Pharmaceutical Society of Great Britain
Invited Speakers: Dirk Barends, National Institute for Public Health and the Environment, NetherlandsRabi Patnaik, Watson Labs Inc., USAGordon Johnston, GPhA, USALawrence Yu, FDA, USAHenning Blume, Socratec R&D, GermanyHilda Koszegi-Szalai, National Institute of Pharmacy, HungaryEric Omsby, Therapeutic Products Directorate, Health Canada, Canada. Yilmaz Capan, Hacettepe University, Ankara, TurkeyPanos Macheras, University of Athens, Greece
 
Deadline for Abstracts: To be confirmed
 
Registration: 8:15
E-mail: science@rpsgb.org
 
   
 
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