Striving for a Safer Tomorrow through Proactive and Collaborative Pharmacovigilance and Risk Management ID# 11652 February 4-5, 2011 Hotel Holiday Inn, Mumbai, India
PROGRAM CO-CHAIRPERSONS
Moin Don Associate Director - Asia Pacific Global System Quality Assurance Johnson & Johnson
Moin Don
Vivek Ahuja
Johnson & Johnson
BAXTER
Vivek Ahuja Director, Pharmacovigilance Asia Pacific Baxter Healthcare.
HIGHLIGHTS
PROGRAM COMMITTEE
Ask the Experts Join international pharmacovigilance experts for an open Q&A session to discuss your most difficult pharmacovigilance challenges.
Balasubramanian S. Practice Director Cognizant
Larisa Nagra Singh General Manager and Director Voisin Consulting Life Sciences
Moin Don
DIA Special Interest Area Communities (SIACs)
FEATURED TOPICS • Recent Market Withdrawals and Current Risk Management Strategies • Resurgent Pharmacovigilance Programme of India and the Role of Stakeholders
Associate Director - Asia Pacific Global System Quality Assurance Johnson & Johnson
• India as the Most Desirable Outsourcing Destination for Pharmacovigilance Services
Gaby Danan
• Pragmatic Approaches to Pharmacovigilance in Light of CIOMS Pharmacovigilance Working Group Recommendations
Senior Director, Global PV and Epidemiology Sanofi-Aventis, Paris
• CRO Challenges When Managing Sponsors Expectations during Clinical Trials
• How to Prepare for Regulatory Inspections
William Gregory
• Comparison of Safety Reporting Regulations in the Asia-Pacific Region
Senior Director, Safety & Risk Management Pfizer
• How to Create a More Efficient and Compliant Local Safety Operation
Chitra Lele
• Safety Database Requirements from a Sponsor/ CRO Perspective
Chief Scientific Officer Sciformix Corp, India
• Career Opportunities in Pharmacovigilance
• Guidelines for DSURs
INTERNATIONAL SPEAKERS WHO SHOULD ATTEND Professionals with experience in clinical safety and who are involved in: • Pharmacovigilance • Clinical research • Risk management • Compliance • Medical information • Regulatory affairs • Academia • Pharmacology All attendees will receive a DIA Certificate of Attendance at the conclusion of the event.
Worldwide Headquarters Drug Information Association, Inc. 800 Enterprise Road, Suite 200 Horsham, PA 19044, USA Regional Offices Basel, Switzerland Tokyo, Japan Mumbai, India Beijing, China
Gaby Danan, Senior Director, Global PV and Epidemiology, sanofi-aventis, Paris Irina Baumer, Senior Director, Medical and Safety Services, ICON Clinical Research Steve Jolley, Consultant, SJ Pharma Consulting Sidney Kahn, Principal Scientist, Sciformix Corporation, USA
LEARNING OBJECTIVES At the conclusion of this workshop, participants should be able to: • Explain key aspects of current global safety reporting requirements for prescription and over-the-counter drugs • Discuss new pragmatic approaches to pharmacovigilance as proposed by the CIOMS working group • Describe the regulatory agency clinical safety and pharmacovigilance inspection program in the US, Europe, and Japan • Identify best practices for quality assurance in post marketing pharmacovigilance and clinical safety
2 DAY 1 | FRIDAY, FEBRUARY 4, 2011
14.00-14.45
SESSION # 7
Implementation of Pharmacovigilance in the National Malaria Programme – A Role Model in India 8.00-9.00
9.00-9.15
REGISTRATION
Dr. Neena Valecha
SESSION # 1
Scientist ‘F’ National Institute of Malaria Research (Indian Council of Medical Research)
Inauguration and Welcome Sultan Ghani
14:45-15.30
Director DIA India
SESSION # 8
Integration of Pharmacovigilance in Indian Medical and Para-Medical Syllabus Dr. Urmila Thatte
9.15-9.30
SESSION # 2
Keynote Address Dr. Y.K. Gupta
Professor and Head Department of Clinical Pharmacology Seth GS Medical College and KEM Hospital
Professor and Head Department of Pharmacology All India Institute of Medical Sciences.
9.30-10.00
10.00-10.45
15.30-16.00
TEA
16.00. 16.45
SESSION # 9
BREAKFAST
SESSION # 3
The Safety Paradigm — Pharmacodiligence to Pharmacovigilance Dr. Vivek Ahuja Director, Pharmacovigilance Asia Pacific Baxter Healthcare
Pragmatic Approach to Pharmacovigilance Practice in the Light of CIOMS Working Committee IV-VI Recommendations Dr. Darshan Bhatt Director Drug Safety Vanthys Pharmaceutical Development
16:45-17:30 10.45-11.30
SESSION # 4
India's Resurgent Pharmacovigilance Programme — PvPI
SESSION # 10
Pharmacovigilance Programme of India – The Journey So Far — Panel Discussion MODERATOR
Dr. Y.K. Gupta
Dr. Y.K. Gupta
PARTICIPANTS
Dr. G.N. Singh 11.30-12.15
SESSION # 5
India as the Most Desirable Outsourcing Destination for Pharmacovigilance Services Balasubramanian S. Practice Director Cognizant
12.15-1.00
SESSION # 6
Getting Ready for Regulatory Inspections the Global Way Moin Don Associate Director - Asia Pacific Global System Quality Assurance Johnson & Johnson
1.00-2.00
LUNCH
Director Central Indian Pharmacopeia Laboratory
Dr. Ramakrishna Deputy Drug Controller, West Zone Pharmabiz Nominee, Representative from the Medical Council of India (tentative)
17:30
END OF DAY 1
3 DAY 2 | SATURDAY, FEBRUARY 5, 2011
2:30-3:15
SESSION #16
Technology – The Backbone of Pharmacovigilance Operations 9:.00-9:45
SESSION # 11
MODERATOR
Lessons to be Learned from Recent Market Withdrawals and Current Risk Management Strategies Dr. Sidney Kahn Senior Principal, Pharmacovigilance Practice Sciformix Corporation, USA
Shiva Kumar Kollunguta Associate Vice President - Life Sciences HCL PANELISTS
Pravin Nath Foresight Group, USA
9:45-10:30
Ravinder Singh
SESSION # 12
The Globalization of Pharmacovigilance – Harmonization versus Fusion Dr. Vivek Ahuja
Santosh Francis Oracle
Goutham Vasudev Aris Global
Jaideep Agarwal 10.30-10.45
Vice President and Head of Operations Patni Computers
TEA BREAK
Kostas Kidos 10:45-11:30
SESSION # 13
The Recent and Forthcoming Changes on PV Legislation in the EU and the US Dr. Sidney Kahn
11:30-12.45
SESSION # 14
QPPV interfaces within the MAH Organization: Experiences and Challenges Dr. Irina Baumer Senior Director, Medical and Safety Services ICON Clinical Research
12:45-1:30
Consultant SJ Pharma Consulting
TEA BREAK
3:45-4.15
SESSION # 17
Signal Detection, Strengthening and Management: Recommended Approaches for Small and Large Companies
4:15-5.15
Safety Management in Clinical Trials. CROs’ Expectations – The Role of SIACs (Special Interest Area Communities) Panel Discussion Dr. Steve Jolley
3:15-3:30
Steve Jolley
SESSION # 15
MODERATOR
Vice President Safety Product Strategy Oracle, USA
SESSION # 18
Open Q&A Session Sidney Kahn Irina Baumer Steve Jolley YK Gupta Vivek Ahuja Moin Don
PANELISTS
Dr. Irina Baumer Sydney Kahn Dr. YK Gupta
1.30-2.30
5:15-5:25
SESSION # 19
Closing Remarks
LUNCH
5.25
CONFERENCE ADJOURNED
Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion and not necessarily that of the organization they represent, or that of the Drug Information Association. Speakers and agenda are subject to change without notice. Recording of any DIA tutorial/workshop information in any type of media, is prohibited without prior written consent from DIA.
TRAVEL AND HOTEL Attendees should make airline reservations as early as possible to ensure availability. Hotel Holiday Inn is holding a block of rooms at the reduced rate below until January 25, 2011, for the DIA event attendees. Room availability at this rate is guaranteed only until this date or until the block is filled. Single/Double INR 6000 + Taxes The Hotel Holiday Inn is located at Sakinaka Junction, Andheri Kurla Road, Andheri East, Mumbai 400059, India Contact Person: Nitin Narayanan, Phone: +91-22-4085-1800 Fax: +91-22-4085-1828 Email: Nitin.Narayanan@ihg.com
MEETING CONTACTS Manoj Trivedi, Senior Consultant, Marketing & Program Development, DIA (India) Private Limited; Cell: +91-9819777493, Fax: +91-22-2859-4762, Email: Manoj.Trivedi@diaindia.org Fahd Khan, Manager Marketing & Program Development, DIA (India) Private Limited; Cell: +91-9223267327, Fax: +91-22-2859-4762, Email: Fahd.Khan@ diaindia.org Pallavi Gokhale, Marketing Assistant, DIA (India) Private Limited; Cell: +91-9004682564; Fax: +91-22-2859-4762; Email: Pallavi.Gokhale@ diaindia.org
DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants. CANCELLATION POLICY: On or before JANUARY 15, 2011 Cancellations must be in writing and received by January 15, 2011. Registrants who do not cancel in writing by that date and do not attend the event will be responsible for the full registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations. If the event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants. Upon cancellation, the administrative fee that will be w ithheld from refund amount is:
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Striving for a Safer Tomorrow Through Proactive and Collaborative Pharmacovigilance and Risk Management Meeting I.D. # 11652 – February 4-5, 2011 – Hotel Holiday Inn, Mumbai, INDIA
REGISTRATION FEES
Registration fee includes refreshment breaks, luncheons, and will be accepted by mail or fax. BASIC RATE
TAXES
TOTAL
Standard Membership
1768
182
INR 1950
Student Membership*
725
75
INR 800
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MEMBER
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BASIC RATE
TAXES
Industry
6216
384
INR 6600
Industry
Academia
4803
297
INR 5100
Academia
Student*
2825
175
INR 3000
Student*
BASIC RATE
TOTAL
EXHIBITS TAXES
BASIC RATE
TAXES
7984
566
INR 8550
TOTAL
6571
479
INR 7050
3550
250
INR 3800
NONMEMBER (Exclusive of Membership) TOTAL
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934
INR 10,000
Tabletop
45331
4669
INR 50,000
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BASIC RATE
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8052
498
INR 8550
Academia
6640
410
INR 7050
Student*
3579
221
INR 3800
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