4th Pharmacovigilance Conference

Overview

Highlights

Updates on recently released GPvP Modules by EMA
Japanese Model of EPPV-A Way Forward for other Asian countries
Challenges in Authoring PSUR for Generic Manufacturers
An Insight in to Drug Induced Liver Injury (DILI)
MedDRA - Challenges in Term Selection in Complex Scenarios
Management of Vaccine Safety
Efficient Management of Literature Searching
PV Inspection Readiness
Global Outsourcing Trends in PV-Indian Potential and Challenges by China, Taiwan, and Latin America
Role of Pharmacogenomics in Drug Safety
Modernizing Pharmacovigilance Processes through Analytics & Cloud
Technology Watch Against Safety Hazard of Spurious and Adulterated Drugs
Challenges in Causality Analysis
Panel Discussion: Compensation for Trial Related Injuries

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

Learning Objectives

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

Hotel & Travel

Attendees should make airline reservations as early as possible to ensure availability. Vivanta by Taj is holding a block of rooms at the reduced rate below until 25th February 2013, for the DIA event attendees. Room availability at this rate is guaranteed only until this date or until the block is filled.

Single INR 7000 (Inclusive of applicable Taxes and Breakfast)

Vivanta by Taj – Yeshwantpur, Bangalore is located at: No. 2275, Tumkur Road,
Yeshwantpur, Bangalore 560022, India

Contact Person: Ashish Dattani, Tel: +91 80 6690 0111
Fax: +91 96 2082 2525; email: Ashish.Dattani@tajhotels.com

Contact Information

Meeting Manager:

Manoj Trivedi, Senior Manager Marketing and Program Development, DIA India
Mobile phone: +91-98-1977-7493
Phone: +91-22-6765-3226
Email: Manoj.Trivedi@diaindia.org

Tabletop Opportunity Available

Program Committee

Previous Next

Program Committee 1-3 of 7

Moin Don

Executive Director and Founder
PVCON Pharmacovigilance Consulting Services, India

Vivek Ahuja

Director, Pharmacovigilance - Asia Pacific
Baxter Healthcare, India

Giridhar R. K.

Vice President
Accenture BPO-Pharma Services, India

Program Committee 4-6 of 7

Ashish Dehade

AVP Life Sciences
Cognizant Technology Solutions, India

Imran Ali

Senior Director and Head Pharmacovigilance, Global Biometrics, QFR
Quintiles, India

Pradip K. Paul, MD,MS

Consultant
Strategic Pharmacovigilance and Risk Management , United States

Program Committee 7-7 of 7

Manoj Sharma

Manager, Pharmacovigilance
Panacea Biotec Ltd, India

Agenda

Day 1 Friday, March 08, 2013

9:15AM - 9:30AM
Inauguration and Opening Remarks
Speaker(s):
- Moin Don
  Executive Director and Founder
  PVCON Pharmacovigilance Consulting Services, India
- Vivek Ahuja
  Director, Pharmacovigilance - Asia Pacific
  Baxter Healthcare, India
9:30AM - 11:00AM
Session 1: Regional PV Updates
Speaker(s):
- Key Note 1: Early Phase Pharmacovigilance Program (EPPV) of Japan and its Relevance to other Asian Countries
  Stewart Geary, MD
  Vice President, Chief Medical Officer, Director, Corporate Medical Affairs HQ
  Eisai Co., Ltd., Japan
- Key Note 2: Management of Vaccines Safety
  Felix M. Arellano, MD
  VP Head of Safety and PV
  GlaxoSmithKline SA, Belgium
11:30AM - 12:30PM
Session 2: The Impact of New EU Regulations Focus on PSURs and ICSRs
Speaker(s):
- Impact of EU regulations - Focus on PSURs and ICSRs
  Vishwas Sovani, MD
  Revogenex, Inc., India
- Impact of EU Regulations – Scope of Change ICSRs
  Mangesh Kulkarni, MD
  Group Head, Drug SAFETY & Epidemiology
  Novartis Healthcare, India
- Periodic Reporting – New Horizons of Scientific assessment
  Sibin Kurian
  Head Medical Safety
  Novartis Healthcare Pvt. Ltd., India
12:30PM - 1:00PM
Session 3: Pharmacovigilance Process and Science
Speaker(s):
- Challenges in PSUR Preparation: Is there any Impact of Human Factor?
  Manoj Sharma
  Manager, Pharmacovigilance
  Panacea Biotec Ltd, India
- Surmounting challenges of causality: A KPO and MAH perspective
  Sanjeev Miglani, MD
  VP, Pharmacovigilance and Medical Writing
  Accenture, India
2:30PM - 4:00PM
Session 4: Afternoon Key Notes
Speaker(s):
- Key Note 3: Haemovigilance and Biovigilance Programs of India
  Surinder Singh, MD
  Director in Charge
  National Institute of Biologicals, India
- Key Note 4: The Future of Drug Safety
  Y. K. Gupta
  Prof. & Head, Department of Pharmacology
  All India Institute of Medical Sciences, India
- Key Note 5: Haemovigilance Software
  Akanksha Bisht
  Member Secretary
  India Haemovigilance Program, India
4:15PM - 5:15PM
Session 5: Practical Aspects in Pharmacovigilance
Speaker(s):
- SUSARs and Principles of Unblinding in CT
  Vineet Shastri
  Associate Medical
  Quintiles, India
- Ecopharmacovigilance: Synergy between Pharmacovigilance & Ecology
  Mandar A. Kelkar
  Sr Manager QA
  Sciformix Technologies, India

Day 2 Saturday, March 09, 2013

9:30AM - 10:15AM
Session 6: PV Emerging Challenges
Speaker(s):
- Key Note 1: US Scope: Take it or Lose it! Are you readjusting?
  Pradip K. Paul, MD,MS
  Consultant
  Strategic Pharmacovigilance and Risk Management , United States
- Key Note 1: US Scope: Take it or Lose it! Are you readjusting?
  Arpad Simon, MD
  Site Head, Drug Safety, Global Development Safety Evaluation Center
  Mitsubishi Tanabe Pharma Development America, United States
- Key Note 2: Possible Solutions to the Global Phenomenon of Underreporting Adverse Events
  Vivek Ahuja
  Director, Pharmacovigilance - Asia Pacific
  Baxter Healthcare, India
11:30AM - 12:00PM
Session 7: Pharmacovigilance Trends
Speaker(s):
- Global Outsourcing Trends in PV - China as a Challenge and Synergy for India
  Naveen Kumar K.K.
  Manager, Pharmacovigilance Center Lifecycle Safety
  Quintiles Technologies (India) Pvt. Ltd., India
- Safety Evaluations: Some Considerations for Safety Issue Assessments
  Stewart Geary, MD
  Vice President, Chief Medical Officer, Director, Corporate Medical Affairs HQ
  Eisai Co., Ltd., Japan
12:30PM - 1:30PM
Session 8: Panel Discussion: Provision for Compensation for Trial
Speaker(s):
- Milind Sardesai
  Project Lead & Domain Consultant – Life Sciences
  Tata Consultancy Services, India
- Syed Mubarak Naqvi, MD
  Director, Clinical Research (India)
  Sanofi, India
- Krishna Sarma
  President - Attorney-at-Law , Patent & Trademark Attorney
  Corporate Law Group, India
2:15PM - 4:30PM
Session 9: Technology and PV Allied Issues
Speaker(s):
- Inspection Preparedness
  Angela K. Pitwood, BSN,RN
  VP Pharmacovigilance
  IPM Safety Services, Inc. (a division of IndiPharm), United States
- Transforming Pharmacovigilance with New Age Architectural Platform: [Social, Mobility, Analytics & Cloud]
  Saikumar Jagannathan
  Senior Director
  Cognizant Technology Solutions, India
- Safety and Risk Management Through Cloud Environment
  Subbaraju Sagi
  CEO & MD,
  Techsol Corporation, India
- Pharmacovigilance - Journey from Social Listening to Social Intelligence
  Satish P. Nair
  Associate Director
  Cognizant, India

Exhibits

The New Insight Into Current Pharmacovigilance Challenges meeting offers interested companies the opportunity to exhibit with a tabletop display.

Tabletop - INR 75,000
Includes:

One (1) complimentary full-meeting registration
One (1) exhibit personnel registrations
One (1) table
Two (2) chairs

Platinum Level Supporter - INR 400,000
Exclusive Opportunity Includes:

One (1) tabletop space
Three (3) complimentary full-meeting registrations
Two (2) exhibit personnel registrations
Various branding and promotion (see application for further details)

Any staff required above those allotted per tabletop must register as a full attendee incurring full registration fees. Additional expenses associated with the exhibit, including special booths, drayage, lights, phone, carpeting, electrical connections, etc., will be the responsibility of the exhibitor.

Useful Links:

Application and Contract for Tabletop

Thank you to our Media Partners

Exhibiting Companies 1-3 of 3

Aris Global Software Pvt. Ltd.
Oviya MedSafe Pvt. Ltd.
TechSol Corporation

Registration Fees

Other Fees

Charitable Nonprofit/Academia: Rs6000.00
Industry: Rs8000.00

Group Discounts

Register 10 from your company and receive the 11th FREE! Contact our group discount representative for details or call +91.98.2058.7798

CANCELLATION POLICY: On or before MARCH 1, 2013

Cancellations must be in writing and received by March 1, 2013. 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. DIA reserves the right to alter the venue, if necessary.

Upon cancellation, the administrative fee that will be withheld from refund amount is:

Member/Nonmember Registration = INR 3,000
Student Registration = INR 500

All refunds will be issued in the currency of original payment

Register Online

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