PHARMACOVIGILANCE CONFERENCE New Insights into Current ... PLEASE CONSIDER THIS FORM AS AN INVOICE...
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Felix Arellano VP Head of Safety and PV GSK Biologicals, Belgium Y. K. Gupta Prof. and Head, Dept. of Pharmacology All India Institute of Medical Sciences INDIA OFFICE Drug Information Association A-303, Wellington Business Park 1 | Andheri-Kurla Road, Marol Andheri East, Mumbai 400059 WORLDWIDE HEADQUARTERS 800 Enterprise Road, Suite 200 | Horsham, PA 19044, USA REGIONAL OFFICES Basel, Switzerland | Tokyo, Japan | Mumbai, India | Beijing, China Washington, DC, USA PHARMACOVIGILANCE CONFERENCE New Insights into Current Pharmacovigilance Challenges ID# 13650 March 8-9, 2013 Vivanta by Taj - Yeshwantpur, Bangalore, India 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 and Cloud • Technology Watch Against Safety Hazard of Spurious and Adulterated Drugs • Challenges in Causality Analysis • Panel Discussion: Compensation for Trial Related Injuries LEARNING OBJECTIVES At the conclusion of this conference, participants will 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 Moin Don Executive Director and Founder PVCON Pharmacovigilance Consulting Services Angela Pitwood VP Pharmacovigilance IPM Safety Services, Inc. (a division of IndiPharm, US) Vivek Ahuja Director Pharmacovigilance Asia Pacific Baxter Healthcare PROGRAM CO-CHAIRS DISTINGUISHED SPEAKER KEYNOTE SPEAKERS All attendees will receive a DIA Certificate of Attendance at the conclusion of the event. Surinder Singh Director in Charge National Institute of Biologicals Stewart Geary Chief Medical Officer Vice President and General Manager of Corporate Medical Affairs Headquarters Eisai Co., Ltd. Pradip Paul PV and Risk Management Consultant Boehringer Ingelheim, US Moin Don Executive Director and Founder, PVCON Pharmacovigilance Consulting Services Vivek Ahuja Director, Pharmacovigilance Asia Pacific, Baxter Healthcare Giridhar R. K. Vice President, Accenture BPO-Pharma Services Imran Ali Senior Director and Head Pharmacovigilance, Global Biometrics, GFR, Quintiles Manoj Sharma Manager Pharmacovigilance Panacea Biotec Ltd. Ashish Dehade AVP Life Sciences Cognizant Technologies Solution Pradip Paul PV and Risk Management Consultant Boehringer Ingelheim, US Felix Arellano VP Head of Safety and PV, GSK Biologicals, Belgium Stewart Geary Chief Medical Officer Vice President and General Manager of Corporate Medical Affairs Headquarters Eisai Co., Ltd. Surinder Singh Director in Charge National Institute of Biologicals Pradip Paul PV and Risk Management Consultant Boehringer Ingelheim, US Y. K. Gupta Prof. and Head, Dept. of Pharmacology All India Institute of Medical Sciences Angela Pitwood VP Pharmacovigilance IPM Safety Services, Inc. (a division of IndiPharm, US) 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 PROGRAM CO-CHAIRS PROGRAM COMMITTEE KEYNOTE SPEAKERS DISTINGUISHED SPEAKER Thank You to Our Media Partner
Transcript of PHARMACOVIGILANCE CONFERENCE New Insights into Current ... PLEASE CONSIDER THIS FORM AS AN INVOICE...
Felix ArellanoVP Head of Safety and PVGSK Biologicals, Belgium
Y. K. GuptaProf. and Head, Dept. of PharmacologyAll India Institute of Medical Sciences
IndIa OffIceDrug Information Association
A-303, Wellington Business Park 1 | Andheri-Kurla Road, MarolAndheri East, Mumbai 400059
WOrldWIde Headquarters800 Enterprise Road, Suite 200 | Horsham, PA 19044, USA
regIOnal OffIcesBasel, Switzerland | Tokyo, Japan | Mumbai, India | Beijing, China
Washington, DC, USA
PHARMACOVIGILANCE CONFERENCE New Insights into Current Pharmacovigilance Challenges
ID# 13650 March 8-9, 2013Vivanta by Taj - Yeshwantpur, Bangalore, India
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 and Cloud• Technology Watch Against Safety Hazard of
Spurious and Adulterated Drugs • Challenges in Causality Analysis • Panel Discussion: Compensation for Trial Related
Injuries
learning objectivesAt the conclusion of this conference, participants will 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
Moin DonExecutive Director and Founder PVCON Pharmacovigilance Consulting Services
Angela Pitwood VP Pharmacovigilance IPM Safety Services, Inc. (a division of IndiPharm, US)
Vivek AhujaDirectorPharmacovigilance Asia PacificBaxter Healthcare
PROGRAM CO-CHAIRS
DISTINGUISHED SPEAKER
KEYNOTE SPEAKERS
All attendees will receive a DIA Certificate of Attendance at the conclusion of the event.
Surinder Singh Director in Charge National Institute of Biologicals
Stewart GearyChief Medical OfficerVice President and General Manager of Corporate Medical Affairs HeadquartersEisai Co., Ltd.
Pradip PaulPV and Risk Management ConsultantBoehringer Ingelheim, US
Moin DonExecutive Director and Founder, PVCON Pharmacovigilance Consulting Services
Vivek AhujaDirector, Pharmacovigilance Asia Pacific, Baxter Healthcare
Giridhar R. K.Vice President, Accenture BPO-Pharma Services
Imran AliSenior Director and Head Pharmacovigilance, Global Biometrics, GFR, Quintiles
Manoj Sharma Manager Pharmacovigilance Panacea Biotec Ltd.
Ashish DehadeAVP Life Sciences Cognizant Technologies Solution
Pradip PaulPV and Risk Management ConsultantBoehringer Ingelheim, US
Felix ArellanoVP Head of Safety and PV, GSK Biologicals, Belgium
Stewart GearyChief Medical OfficerVice President and General Manager of Corporate Medical Affairs HeadquartersEisai Co., Ltd.
Surinder Singh Director in Charge National Institute of Biologicals
Pradip PaulPV and Risk Management ConsultantBoehringer Ingelheim, US
Y. K. GuptaProf. and Head, Dept. of PharmacologyAll India Institute of Medical Sciences
Angela Pitwood VP Pharmacovigilance IPM Safety Services, Inc. (a division of IndiPharm, US)
Who should attendProfessionals with experience in clinical safety and who are involved in:
• Pharmacovigilance• Clinical research• Risk management• Compliance
• Medical information• Regulatory affairs• Academia• Pharmacology
PROGRAM CO-CHAIRS
PROGRAM COMMITTEE
KEYNOTE SPEAKERS
DISTINGUISHED SPEAKER
Thank You to Our Media Partner
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DAY 1 | FRIDAY, 8 MARCH 20139.15-9.30 INAUGURATION AND OPENING REMARKS Kaushik DesaiDirector, DIA India Moin DonExecutive Director and Founder PVCON Pharmacovigilance Consulting Services Vivek AhujaDirector, Pharmacovigilance Asia Pacific, Baxter Healthcare
9.30-11.00 SESSION 1
Regional PV Update9.30-10.15 KEY NOTE 1: EPPV Program of PMDA and Its Relevance to Other Asian Countries
Stewart GearyChief Medical Officer, Vice President and General Manager of Corporate Medical Affairs Headquarters Eisai Co., Ltd.
10.15-11.00 KEY NOTE 2: Management of Vaccines SafetyFelix ArellanoVP Head of Safety and PV, GSK Biologicals, Belgium
11.00-11.30 TEABREAK
11.30-12.30 SESSION 2
The Impact of New EU Regulations Focus on PSURs and ICSRsImpact of EU Regulations – Scope of Change Vishwas SovaniCountry Manager, Revogenex IncKey Changes - ICSRs Mangesh KulkarniGroup Head - Drug Safety and Epidemiology Novartis Healthcare Pvt. Ltd.Key Changes (Scientific Assessment) – PBRERs/ PSURs Sibin KurianHead Medical Safety, Novartis Healthcare Pvt. Ltd.
12.30-13.30 SESSION 3
Pharmacovigilance Process and Science 12.30-13.00 Challenges in PSUR Preparation: Is there any Impact of Human Factor?
Manoj SharmaGlobal Pharmacovigilance Division Panacea Biotec Ltd.
13.00-13.30 Surmounting Challenges of Causality Analysis: A MAH and KPO Perspective
Sanjeev MiglaniVP, Pharmacovigilance and Medical Writing Accenture
13.30-14.30 NETWORKING LUNCH
14.30-16.00 SESSION 4
14.30–15.00 KEY NOTE 3: Haemovigilance and Biovigilance Programs of India
Surinder SinghDirector in Charge, National Institute of Biologicals
15.00–15.15 Haemovigilance SoftwareAkanksha BishtMember SecretaryIndia Haemovigilance Program
15.15–16.00 KEY NOTE 4: The Future of Drug SafetyY. K. GuptaProf. and Head, Dept. of PharmacologyAll India Institute of Medical Sciences
16.00-16.15 TEA/COFFEE
16.15-17.15 SESSION 5
Practical Aspects in Pharmacovigilance 16.15-16.45 SUSARs and Principles of Unblinding in CT
Vineet ShastriAssociate Director, India, Quintiles
16.45-17.15 Ecopharmacovigilance: Synergy Between Pharmacovigilance and Ecology
Mandar KelkarSenior Manager, QASciformix Technologies
DAY 2 | SATURDAY, 9 MARCH 20139.30-11.00 SESSION 6
PV Emerging Challenges9.30-10.15 KEY NOTE 1: Take It or Leave It
Pradip PaulPV and Risk Management Consultant, Boehringer Ingelheim, US
10.15-11.00 KEY NOTE 2: Possible Solutions to the Global Phenomenon of Underreporting Adverse Events
Vivek Ahuja Director, Pharmacovigilance Asia Pacific, Baxter Healthcare
11.00-11.30 TEA BREAK
11.30-12.30 SESSION 7
Pharmacovigilance Trends11.30-12.00 Global Outsourcing Trends in PV - China as a Challenge and Synergy for India
K. K. NaveenAssociate Director, China, Quintiles
12.00-12.30 PK, PD and Pharmacogenomics as Predictors for Drug Safety
Ajit RoyManager R and D; Actavis Inc., US
12.30-13.30 SESSION 8
Panel Discussion: Provision for Compensation for Trial Related InjuriesMilind SardesaiProject Lead and Domain Consultant - Life SciencesTata Consultancy ServicesMubarak NaqviDirector, Clinical Research (India) SanofiKrishna SarmaManaging PartnerCorporate Law Group
13.30-14.15 NETWORKING LUNCH
14.15-16.30 SESSION 9
Technology and PV Allied Issues 14.15-14.45 Getting Ready for PV Inspections
Angela PitwoodVP Pharmacovigilance IPM Safety Services, Inc. (a division of IndiPharm, US)
14.45-15.15 Modernizing Pharmacovigilance Processes Through Social Mobile Analyticals and Cloud
Saikumar JagannathanSenior Director, Cognizant Mobility Practice
15.15-15.30 TEA BREAK
15.30-16.00 Safety and Risk Management Through Cloud Environment
Subbaraju SagiManaging DirectorTechsol Corporation
16.00-16.30 Pharmacoviligance - Journey from Social Listening to Social Intelligence
Satish P. NairAssociate Director, Cognizant
16.30 CONCLUDING REMARKS
PLEASE CONSIDER THIS FORM AS AN INVOICE
NEW INSIGHTS INTO CURRENT PHARMACOVIGILANCE CHALLENGESMeeting ID #13650 – March 8-9, 2013 – Vivanta by Taj - Yeshwantpur, Bangalore, India
TRAVEL AND HOTELAttendees 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 guaran-teed only until this date or until the block is filled.
Single INR 7000 (Inclusive of Taxes and Breakfast)Vivanta by Taj – Yeshwantpur, Bangalore, No. 2275, Tumkur Road, Yeshwantpur Bangalore 560022, India, Tel: +91.80.6690.0111
Contact Person: Ashish Dattani; Cell: +91.96.2082.2525; Tel: +91.96.2082.2525; email: [email protected]
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Andheri East, Mumbai 400059
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