IPC-USP 12th Science & Standards Symposium

Partnering Globally for 21st Century Medicines APRIL 1617, 2013

ITC Maurya, New Delhi INDIA

~ AGENDA ~
(As of March 30 , 2013: Subject to Change)

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Day 1: TUESDAY, APRIL 16, 2013

8:009:00 a.m. 9:009:45 a.m. Registration Opening Session: Welcoming Remarks and Greetings Moderator: Dr.V.Srini Srinivasan, Executive Vice President and Chief Scientific Officer, USP. 1. 2. 3. Indian Pharmacopoeia Commission a. Dr. B. Suresh, Chairman, IPC & President, PCI U.S. Pharmacopeial Convention Dr. Roger Williams, Chief Executive Officer and Chair, Council of Expert, USP Government Officials i. Indian Government a. Dr.GN Singh, Drugs Controller General of India(DCGI) b. Dr. Surinder Singh, Director, National Institute of Biologicals c. Dr. HG Koshia, Commissioner, FDCA Gujarat ii. United States FDA a. Mr. Bruce Ross, Country Director, US FDA-India 4. 5. World Health Organization TBC National Institute of Biological Standardization and Control a. Dr. Stephen Inglis, Director, NIBSC

9:4510:30 a.m. 10:30-11:00-a.m.

Keynote Speaker: A Common Quality Platform for Biological Medicines a. Ms. Kiran Mazumdar Shaw, CEO Biocon Coffee/Tea Break

IPC-USP 12 Science & Standards Symposium April 16-17, 2013 New Delhi, India

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11:00 a.m.1:30 p.m.

General Session I: Chemical Medicines and Excipients Moderator: Dr. Anthony Raj Gomas, USP Medicines Compendium Expert Committee 1. 2. 3. The Medicines Compendium: Performance Based Monographs with Reference Procedures, Dr. Anthony Raj Gomas, Mylan Laboratories. Industry Use of Medicines Compendium Approaches,Dr.Nicholas Cappuccino, Dr.Reddys Laboratories. USP-NF Monograph Modernization: Application of the Reference Procedure, Dr.Todd Cecil, USP Dosage Form Performance-General Chapter <12> Assessing Drug Product Performance and Optimal Bioequivalence, Dr.Roger Williams, USP. New Pharmacopeial Approaches to Excipient Monographs, Dr.Sameer Navalgund, USP. Perspectives from the Indian Pharmacopeia CommissionIPC Chemical Medicines ,Mr.SM Mudda, Micro Labs Panel Discussion

4. 5. 6.

1:302:30 p.m. 2:30 p.m. - 5:00 p.m.

Lunch General Session II: Biological Medicines Moderator: Dr. Dhananjay Patankar, USP Medicines Compendium Expert Committee 1. 2. 3. 4. 5. 6. Application of the Performance Based Monograph to Biological Standards , Dr. Dhananjay Patankar, Syngene International Limited USP-NF General Chapters on Characterization of Biotherapeutics, Dr.Tina Morris, USP Therapeutic Protein and Vaccine Monographs in the Medicines Compendium , Dr.Ranjan Chakrabarti, USP. Monographs for Biosimilars: Industry Need and Use , Dr.Abhijit Bharve, Biocon Limited Biologic Reference Standards ,Dr.Adrian Bristow, NIBSC Comparability of Biosimilar Products Perspectives from the Indian Pharmacopeia Commission,Dr Anurag Rathore, Indian Institute of Technology, Delhi. Panel Discussion

5:00 p.m - 5:30 p.m.

Reflections on the Days Discussions Moderator: Dr.V.Srini Srinivasan, Executive Vice President and Chief Scientific Officer, USP. Adjourn

5:30 p.m.

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Day 2: WEDNESDAY, APRIL 17, 2013

8:009:00 a.m. 9:00 11:00 a.m. Registration TRACK I: Chemical Medicines and Excipients -Evolution of Validation Practices Moderator: Dr. Milind Joshi ,USP South Asia Stake Holder Forum 1. ICH Q2 and General Chapter <10> Assessing Validation Parameters for Reference and Acceptable Procedures Dr.Todd Cecil,USP Precision and Accuracy Dr.Hefei Yang,Meddimune Linearity Dr.Hefei Yang,Meddimune Analytical Target Profile Dr.Joachim Ermer,Sanofi Aventis 4. 5. Analytical Method Validation -Current Practices, Industry Perspective Dr.Rajiv Desai,Dishman Pharmaceuticals 5. 11:0011:30 a.m. 11:30 a.m.1:30 p.m. Tea Break TRACK I: Chemical Medicines and Excipients-Consideration of Novel Formulations Moderator: Dr.Albinus DSa,US FDA-India 6. 6. 7. 8. 9. Solid Oral Formulations Advances Dr.Sukhjeet, Panacea Biotec Advances in Topical Delivery Dr.Vinod Shah,USP Consultant Targeted Delivery of Injectables Dr.N.Subramanian,Agila Specialities Performance Tests for Novel Formulations Dr.Vinod Shah,USP Consultant 8. 9. 7. Evolving Regulatory Framework for Obtaining WHO Prequalification of Vaccines in Developing Countries Dr.Carmen Rodriguez Hernandez,WHO Alternative to Animal Testing in the Quality Control of Vaccines and its Regulatory Acceptance.Dr.Mahesh Bhalgat,Biological E Limited. Novel Vaccine Adjuvants,Dr.Manish Gautam,Serum Institute. Comparing the Opportunities and Challenges in Thermostable Vaccines with Conventional Vaccines,Dr.Rajesh Jain, Panacea Biotec. 3. TRACK II Session II: Biological Medicines - Biotherapeutics Moderator: Dr. Rustom Mody, USP Medicines Compendium Expert Committee 1. Monograph Tests for Monoclonal Antibody Therapeutics Dr.Venkat Mukku,USP Consultant Biosimilar Guideline in Korea & ASEAN Countries Mr.Boon Jong Kim,Celtrion Biosimilar Guideline in Latin American Countries Mr.Daniel Guedes,Bio-ManguinhosFiocruz Impact of Product Variants such as Glycosylation on Product Functional Activity, PK, Immunogenicity, Stability, in the Context of Biosimilar Dr.Rustom Mody,Lupin Pharma The New USP Bioassay General Chapters,Dr.Tina Morris,USP

2. 2. 3. 4.

TRACK II: Biological Medicines-Vaccines Moderator: Dr.Mahesh Bhalgat, USP Medicines Compendium Expert Committee

10. Special Considerations with Multivalent Vaccines ,Dr.Sunil Gairola,Serum Institute 1:302:30 p.m. 2:304:00 p.m. Lunch Closing Plenary Session: Global Pharmacopeial Harmonization Moderator: Dr.Roger Williams,USP 1. WHOs Good Pharmacopeial Practices, TBC 2. USP Perspective: Theory and Practice,Ms,Angela Long,USP 3. Pharmacopeias: The Dos and Donts ,Dr.Roger Williams,USP Wrap-up Session: Track Summary Presentations 1. Chemical Medicines, Dr. Anthony Raj Gomas, Chair-USP Medicines Compendium Expert Committee 2. Biological Medicines, Dr. Dhananjay Patankar, Chair-USP Medicines Compendium Expert Committee
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4:005:00 p.m.

IPC-USP 12 Science & Standards Symposium April 16-17, 2013 New Delhi, India

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