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IPC-USP 8th Annual Scientific Meeting

February 11–12, 2009
Taj Krishna Hotel
Hyderabad, India

Agenda

Wednesday, February 11, 2009
8:30 a.m. ASM Registration and Information
9:00 a.m.

Opening Plenary Session (Moderator – Dr. K.V.Surendra Nath)
Venue: Ball Room

Honored Guests

  • Indian Pharmacopoeia Commission (Dr. G.N. Singh, Secretary cum Scientific Director)
  • Ministry of Chemicals and Fertilizers (Dr. Jayashree Gupta, Chairperson-cum-Managing Director of IDPL)
  • The United States Pharmacopeial Convention (Dr. Roger L. Williams, CEO & Executive Vice President, USP)

Keynote Address
IPC-USP Annual Scientific Meeting Overview
10:30 a.m. Break

Inauguration of Poster Presentations by Dr. Roger Williams and Dr. Valerio Reggi
11:00 a.m. - 1:30 p.m.

Session I: Wednesday, February 11, 2009

Track I - Drug Substances–Adulterants (Venue: Ball Room 1 & 2)

  • Heparin, Glycerin–Case Studies and Compendial Implications
  • Counterfeits/ Substandards
  • Spectral Libraries

Topic 1 Dr. Darrell Abernethy, USP  (1.1MB)
Topic 2 Dr. Valerio Reggi, IMPACT, WHO  (1.8MB)
Mr. Omprakash Sadhwani, FDA  (188KB)
Topic 3 Dr. William Koch, USP  (892KB)

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

Session I: Wednesday, February 11, 2009

Track II - Drug Product Manufacturing and Control (Venue: Ball Room 3)

  • Pharmaceutical Quality Systems: ICH Q8, Q9, and Q10
  • BA, BE, Dissolution
  • USP Performance Tests/PVTs

Topic 1 Mr. Antony Raj Gomes, Shasun Chemicals and Drugs Ltd  (649KB)
Dr. Milind Joshi, J.B.Chemicals & Pharmaceuticals Ltd  (822KB)
Topic 2 Dr. Ranjani, PharMantra Consulting Services  (2.7MB)
Topic 3 Dr. Roger Williams, USP  (1.4MB)

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

Session I: Wednesday, February 11, 2009

Track III - Biologics and Biotechnology (Venue: Garden Room)

  • Biosimilars / Compendial Opportunities
  • Bioassays / Cell Based Bioassays

Topic 1 Dr. Venkat Mukku, Member, USP Expert Committee  (2.3MB)
Mr. Samir S Rao, Intas Bio Pharmaceuticals Ltd  (333KB)
Dr. Jai Prakash, IPC  (140KB)
Dr. K. Satyamoorthy, Manipal Life Sciences Centre  (1.1MB)
Topic 2 Dr. Sriram Akundi, Biocon Ltd  (5.7MB)

1:30 p.m. Lunch
2:30 p.m. – 5.00 p.m.

Session II: Wednesday, February 11, 2009

Track I - Drug Substances—Impurities (Venue: Ball Room 1 & 2)

  • Residual Solvents
  • Organic / Degradants –Synthesis, Isolation, Characterization
  • Differences genotoxic, metabolites and other organic impurities

Topic 1 Dr. Darrell Abernethy, USP  (970KB)
Dr. Pramod Dalvi, Watson Pharma Pvt Ltd  (1MB)
Mr. P. Krishna Rao, General Manager - Natco Pharma Ltd
(Representing Agilent Technologies India Pvt Ltd)  (1.4MB)
Topic 2 Dr. Rajiv A. Desai, Matrix Laboratories Ltd  (332KB)

4:00 p.m. Break
2:30 p.m. – 5.00 p.m.

Session II: Wednesday, February 11, 2009

Track II - Drug Product Manufacturing and Control–Microbiology (Venue: Pearl Room)

  • Harmonized Microbial Limit Tests
  • Revised Sterility Tests
  • Future Directions/The Revolution in Dehydrated Culture Media
  • Herbs and Herbal Products

Topic 1 Dr. Radhakrishna Tirumalai, USP  (1.3MB)
Topic 2 Dr. Radhakrishna Tirumalai, USP  (1.7MB)
Dr. Shantaram Nagpure, Fresenius Kabi Oncology Ltd  (314KB)
Topic 3 Dr. Radhakrishna Tirumalai, USP  (1MB)
Dr. Vishal Warke, Himedia Laboratories Ltd  (4.6MB)
Topic 4 Dr. S.C. Mathur, IPC  (539KB)

2:30 p.m. – 5.00 p.m.

Session II: Wednesday, February 11, 2009

Track III - Biologics and Biotechnology (Venue: Garden Room)

  • Novel Drug Delivery System using Liposomes
  • Biotherapeutic Protein and Characterization
  • Application of Mass Spectrometry based Proteomics in Biotherapeutics
  • Novel Vaccines

Topic 1 Dr. D.Rambhau, NATCO Pharma  (5.7MB)
Topic 2 Dr. Maruthi Sai, Biological E Ltd  (1.9MB)
Topic 3 Mr. Harsha Gowda, Research Scientist - Institute of Bioinformatics (Representing Agilent Technologies India Pvt Ltd)  (4.4MB)
Topic 4 Dr. V.K. Srinivas, Bharat Biotech Int. Ltd  (2.8MB)

2:30 p.m. – 5.00 p.m.

Session II: Wednesday, February 11, 2009

Special Track - Reference Standards (Venue: Ball Room 3)

  • Measurement Science and Certified Reference Materials
  • Reference Standards and Clinical Research
  • Monograph Developments & Update

Topic 1 Dr. William Koch, USP  (2.8MB)
Topic 2 Dr. S.K. Gupta, ICRI  (519KB)
Topic 3 Dr. Raman M Singh, IPC  (309KB)

Thursday, February 12, 2009
9:00 a.m. – 10.30 a.m.

GENERAL SESSION: Thursday, February 12, 2009

Metal Impurities (Venue: Ball Room 1 & 2)

  • USP's Metal Impurities Initiative
  • Analytical Methodologies
  • Toxicology Limits

Speakers Dr. Darrell Abernethy, USP  (1.3MB)

Mr. P. Raghuram, Hetero Drugs Ltd  (1.4MB) | Video 1 (3MB) | Video 2 (2MB)

Dr. Darrell Abernethy, USP  (852KB)

10:30 a.m. Break
11:00 a.m. – 1.30 p.m.

SESSION III: Thursday, February 12, 2009

Track Ia - Drug Substances—Monographs and General Chapters
(Venue: Ball Room 1 & 2)

  • Redesigned USP-NF Monographs
  • General Chapters—New Directions
  • USP, Pending, Non-US—Monograph Acquisition & Development Process

Topic 1 Dr. Darrell Abernethy, USP  (995KB)
Topic 2 Dr. Darrell Abernethy, USP  (866KB)
Topic 3 Dr. Shawn Dressman, USP  (945KB)
Dr. Poonam Kumar, Jubilant Organosys Ltd  (231KB)

11:00 a.m. – 1.30 p.m.

SESSION III: Thursday, February 12, 2009

Track Ib – Drug Substances—Impurities (Venue: Ball Room 3)

  • Genotoxic Impurities
  • Applications of Ion Chromatography in Pharmaceutical Industry
  • Chiral Impurity Methods: Case Study

Topic 1 Dr. Vijay Vitthal Mathad, Megafine Pharma Pvt Ltd  (7.5MB)
Topic 2 Mr. S. Thiagarajan, Metrohm India Ltd  (1.4MB)
Topic 3 Mr. Lakshmi Narayana, Daicel Chiral Technologies (India) Pvt Ltd  (478KB)

11:00 a.m. – 1.30 p.m.

SESSION III: Thursday, February 12, 2009

Track IIa – Drug Product Manufacturing and Control—Microbiology
(Venue: Pearl Room)

  • Rapid Micro Tests
  • Environmental Monitoring

Topic 1 Dr. Radhakrishna Tirumalai, USP  (1MB)
Topic 2 Dr. Radhakrishna Tirumalai, USP  (1.2MB)
Dr. Shantaram Nagpure, Fresenius Kabi Oncology Ltd  (215KB)

11:00 a.m. – 1.30 p.m.

SESSION III: Thursday, February 12, 2009

Track IIb – Drug Product Manufacturing and Control
(Venue: Garden Room)

  • Method Development in a QbD Environment
  • Compendial Implications
  • Acceptable, Equivalent, Better
  • Road ahead for IPC – Power of Partnership

Topic 1 Dr. R. Rajan, Elder Pharmaceuticals Ltd  (139KB)
Topic 2 Dr. Roger Williams, USP  (1.7MB)
Dr. Somani, CDSCO
Topic 3 Dr. Todd Cecil / Dr. Water Hauck, USP (by video) (36MB)
Topic 4 Dr. P.V. Venugopal, Representing IPC  (49KB)

1:30 p.m. Lunch
2:30 p.m. Closing Session (Venue: Ball Room 1, 2 & 3)

New Compendial Initiatives

  • IPC Updates (Dr.G.N. Singh)
  • USP Updates
    • Council of Experts (CoE) 2010-15 (Dr. Roger Williams)
    • Compendial Process Topics (Ms. Angela Long)
      • Pharmacopeial Forum (PF) Redesign
      • Nominations for the 2010-2015 CoE, Expert Committees
    • Pharmacopeial Education (Dr. John Santell)

Topic 1 Dr. G.N. Singh, IPC
Topic 2 Dr. Roger Williams, USP  (826KB)
Ms. Angela Long, USP  (2.3MB)
Mr. John Santell, USP  (1.5MB)

3:30 p.m. Break
3:45 p.m. – 4:45 p.m. Track Reports

  • Drug Substances
  • Drug Product Manufacturing and Control
  • Drug Product Manufacturing and Control - Microbiology
  • Biologics and Biotechnology(Dr.Venkat Mukku)
  • Reference Standards(Dr.William Koch)

Topic 1 Dr. Shawn Dressman, USP  (674KB)
Topic 2 Dr. Milind Joshi, J.B.Chemicals & Pharmaceuticals Ltd  (700KB)
Topic 3 Dr. Radhakrishna Tirumalai, USP  (667KB)
Topic 4 Dr. Venkat Mukku, Member, USP Expert Committee  (605KB)
Topic 5 Dr. William Koch, USP  (501KB)

Declaring Poster Winners (Dr. Roger Williams and Dr. G.N. Singh)
5:00 p.m. 2009 Annual Scientific Meeting Adjourns