IPC–USP 7th Annual Scientific Meeting - India

Quality of Manufactured Medicines: APIs, Dosage Forms,
Biologics and Biotechnology, and Special Topics

February 6–7, 2008
Hyderabad International Convention Center (HICC)
Hyderabad, India

Agenda

Wednesday, February 6, 2008

7:00 a.m.–6:00 p.m. ASM Registration and Information  
8:00 a.m.–10:30 a.m. Opening General Session(Kumud Sampath to moderate)
Opening Remarks
• Indian Dignitaries
  o Government of India Dr. M. Venkateswarlu
  o Government of the State of Andhra Pradesh J. Hari Narayan
o Indian Pharmacopoeia Commission Dr. G.N. Singh
oNIPER Hyderabad  (928KB) Dr. Prakash Dhiwan
  • USP Board of Trustees  (1.9MB) Dr. Ellen Cosgrove
• USP Dr. Darrell R. Abernethy
Reports  
  • IPC-USP MOU Report  (561KB) G.N. Singh and Kumud Sampath
  • USP-India Overview  (1.9MB) Kumud Sampath
   
  Discussion
  Advisory Panel Reports  
  • Monographs and Reference Standards  (560KB) Dr. Antony Raj Gomes
  • Dietary Supplements—Botanicals Dr. James Griffiths
  • B&B—Vaccines Dr. Tina Morris
• B & B Proteins and Polysaccharides  (100KB) Dr. Anand Kumar
   
Discussion  
  Annual Scientific Meeting Overview  
  Housekeeping Announcements  
     
11:00 a.m. – 11:30 a.m. Inauguration of Poster Session  (492KB) Dr. Ellen Cosgrove
11:30 a.m.–1:30 p.m. Session I
  Track I – API’s: Polymorphism in Drug Substances
  • USP Flexible Monograph Approach for Polymorphs  (488KB) Dr. Anthony DeStefano
  • Polymorph Testing How, When and Why?  (572KB) Dr. Jason Gray
  • Analytical Techniques to Screen for Polymorphs  (2.4MB) Dr. Vyas and Mr. T Sundar
   
  Track II – Dosage Forms: Regulatory Environment – Generic Drugs
  • Regulation of Generic Drugs in India Dr. M. Venkateswarlu
  • USP's Verification Programs Experience to Date  (1.6MB) Richard Aleman
   
  Track III – Biologics & Biotechnology: Potency Bioassays
  • USP's New General Chapters  (392KB) Dr. Tina Morris
  • Potency Bio-assays GCSF - Industry Perspective U.S.A  (113KB) Dr. Venkat Mukku
  • Potency Bio-assays GCSF, Industry Perspective India  (627KB) Dr. D. Patankar
.  
1:30 p.m.–2:15 p.m. Lunch
   
2:15 p.m.–5:45 p.m. Session II
   
2:15 p.m.–3:45 p.m. Track I – APIs: Emerging Technologies in Quality Control & Assurance
  • Implementing New Analytical Technologies to bring products to Market with greater efficiency  (2MB) Mathieu Laouenan Waters
  • Empowering Prominence - Multi-vendor support and beyond  (2.1MB) Dr.Masayuki Nishimura, Shimadzu
  • New Trends in Chiral Chromatography  (360KB) Ch.Lakshmi Narayana, Daicel
  • Emerging Technology in Quality Control and , TA Instruments Assurance  (4.2MB) S. Bala Krishnan
   
4:15 p.m.–5:45 p.m. Track II - Dosage Forms Fixed Dose Combinations - Approach and Rationale  (509KB)
  • Pharmacological Appraisal of FDC Therapy  (581KB) Dr. Darrell Abernethy
  • Regulatory Approach to Approval of FDCs Dr. Milind Joshi
  • Regulatory Approach to Approval of FDCs Dr. Darrell Abernethy
   
  Track III – Biologics & Analytical Characterization of Biopharmaceuticals Biotechnology
  • Horizontal Standards Glycan Project, Future Directions  (636KB) Dr. Tina Morris
  • Product Characterization (r-EPO) - Protein Therapeutics TBA
  • Product Characterization - Monoclonal Antibodies  (537KB) Dr. Venkat Mukku

Thursday, February 7, 2008

9:30 a.m.–1:30 p.m. Session III
   
9:30 a.m.–10:30 a.m. Bio–Asia Session I
  US Biologics and Biotechnology Products in USA–Regulatory & Compendial Environments
  Dr. Darrell Abernethy
   
  Track II – Dosage Forms: Dissolution Testing in Regulation of Pharmaceutical Quality
  • Bioequivalence  (365KB) Dr. Prashant Bodhe
  • Performance Verification Testing  (711KB) Dr. William Koch
   
9:30 a.m. – 11:30 p.m. Track I – APIs: Genotoxic Impurities – Regulation & Control
. • Indian Regulatory Perspective  (511KB) Dr. Prakash Diwan
  • US and European Regulatory Perspective  (378KB) Dr. Anthony DeStefano
  • Indian Manufacturer Perspective  (96KB) Dr. C. Satyanarayana
   
11:30 a.m.–12:00 p.m. Morning Break
   
12:00 p.m.–1:30 p.m. Special Track IV – Nanotechnology in Pharmaceutical Products
  • Novel Formulations - Alternative Formulations and Novel  (1.9MB) Dr. Rustom Mody
  • Delivery Systems for Biotherapeutics
  • Nanosizing of Drugs and Scalability Challenges Dr. Rama Mukherjee
  • US Perspectives  (2.2MB) Dr. William Koch
   
1:30 p.m.–2:15 p.m. Lunch
   
2:15 p.m.–4:15 p.m. Session IV Special Topics
  Track I – APIs: Inorganic Impurities – Heavy Metals
  • Heavy Metals-USP Perspective  (328KB) Dr. Darrell Aberneth
  • Heavy Metals-IPC Perspective  (292KB) Dr. Raman Mohan Singh
  • Heavy Metals-Industry Perspective  (515KB) P. Raghuram
   
  Track II – Dosage Forms: Functionality Testing of Excipients
  • Excipient Functionality: Specifications and Monographs  (367KB) S.D. Joag
  • Excipient Functionality  (696KB) Dr. Ashok Katdare
  • Drug-Excipient Interactions-Detection and Characterization  (407KB) Dr. AL Prasad
   
3:00 p.m. Track III – Biologics & Impurities & Residuals in Biotechnology Products Biotechnology
  • Ancillary and Process Materials Protein A and Fetal Bovine Serum  (477KB) Dr. Tina Morris
  • Process Residuals Ancillaries and Process Material  (87KB) Dr. Samir Roy
  • Host Cell Impurities HCP, DNA etc  (663KB) Dr. Ravi Sirdeshmukh
   
2:15 p.m.–4:15 p.m. Special Track IV – Interaction with USP Scientists, Group Debate, and Q &A
  (Two concurrent sessions)
   
  Documentary Standards
  USP Chapter <671> Containers-Performance Testing  (361KB) Dr. Abernethy
  Revised USP System Suitability Parameters  (629KB) Dr. DeStefano
   
  Reference Standards
  Certified Reference Material for Compendial Applications  (340KB) Dr. Koch
  USP Reference Standards Development and Usage  (767KB) Steve Lane
   
4:15 p.m.–4:45 p.m. Afternoon Break
   
4:45 p.m.–6:00 p.m. Closing General Session Wrap-up Session  (605KB)
  Scientific Approaches
  • IPC Summary and Next Steps
  • USP Documentary Standards: Summary/Next Step Dr. Abernethy
  • USP Reference Materials: Summary/Next Steps Dr. Koch
  • Announcement of Winner of Poster Session
   
6:00 p.m. 2008 Annual Scientific Meeting Adjourns