Indian Society for Clinical Research PHARMACOVIGILANCE COUNCIL announces 5th ANNUAL SYMPOSIUM
“Pharmacovigilance in India - Navigating the Transforming Landscape”
September 28, 2018 (Friday) Timing: 8.00 am to 6.00 pm Venue: Radisson Hotel, X-22, MIDC Central Road, Andheri East, Mumbai, Maharashtra, 400 093, India
Highlights of the Symposium: The symposium will provide different insights from key stakeholders such as Industry, HCPs, Regulators
and Academia on current Pharmacovigilance requirements, upcoming changes in regulations, Global Pharmacovigilance Practices, and opportunities and challenges in effective management of Pharmacovigilance operations.
Objective: To leverage India's status as a leader in the global pharmacovigilance
domain for augmenting Indian pharmacovigilance standards by
integrating the views of all the relevant stakeholders such as the
pharmaceutical industry, CROs, pharmacovigilance service providers,
investigators, clinicians, academia, the CDSCO and the PvPI.
Target Audience: Pharmaceutical Industry
Contract Research Organizations
Senior Medical Officers
Government Agencies
Non-profit Organizations/Associations
Clinical Investigators & Health Care Professionals
Academia Who Should Attend? Vice Presidents, Directors/CEOs, Heads, Managers/Leads of
Pharmacovigilance Strategy
Drug Safety/Risk Management
Information and Clinical Data Management
Clinical Research
Research & Development
Product Safety/Assurance Assessment
Patient Safety, Outcomes Research & Data Analysis
Epidemiology Project Management
Regulatory Affairs and Compliance
Sales & Marketing
Biotech Manufacturers
Hurry!!! Only for 100 Participants
Last Date for Registration: 27
th September 2018
Delegate Fee : Academia - Rs. 3000/- per person
ISCR Member - Rs. 5500/-per person (For Individual & Corporate
Members – AMOs) Non-Member- Rs. 6000/-per person
Group Registration Benefit: One registration free on every five registrations from the same organization (the sixth delegate’s registration will be free)
Online Registration (Mandatory) : http://www.iscr.org/events-registration/ Offline Payment : Cheque /DD payable at Mumbai should be made in favour of “Indian Society for Clinical Research” & mailed to us at: ISCR Secretariat, C/o. Pfizer Centre, The Capital, 1802, 18th Floor, Plot No. C- 70, ‘G’ Block, Bandra Kurla Complex, Bandra (E), Mumbai – 400 051.
Online Payment: http://www.iscr.org/payment-events-workshops/
For any query please contact on Email:
[email protected] or call on - +91-8454827775
AGENDA
TIMING TOPICS SPEAKERS
8:00 am - 9:00 am REGISTRATION & BREAKFAST
9:00 am - 9:30 am Welcome Address Dr J Vijay Venkatraman - Chair, ISCR Pharmacovigilance Council
Inauguration
Chief Guest’s Address Dr Chirag Trivedi - President, ISCR
Guest of Honour’s Address Dr Sanish Davis - General Secretary, ISCR
Felicitation Dr Ravi Wankhedkar - National President, Indian Medical Association
Session 1: Keynote Addresses
9:30 am - 10:05 am A holistic overview of PV training for stakeholders
Moin Don - President and CEO, PVCON Consulting
10.05 am - 10:40 am Keynote Address Dr Jai Prakash - Senior Principal Scientific Officer, Indian Pharmacopoeia Commission
10:40 am - 11:00 am TEA BREAK
Session 2: Advances in PV
11:00 am - 11:30 am PV Automation Dr Krishna Asvalayan – Head of Pharmacovigilance, Ancla Consultancy Services
Session 3: Perspectives on Pharmacovigilance Awareness & Challenges in India
Moderator: Dr J Vijay Venkatraman, Managing Director & CEO, Oviya MedSafe
11:30 am-12:45 pm
IMA Perspective Dr Ravi Wankhedkar - National President, Indian Medical Association
ADR Monitoring Center Perspective
Dr Sudhir Pawar - Professor and Head, Department of Pharmacology, LTMMC & GH
Consumer Perspective Prof. Bejon Kumar Misra - Founder Director, Patient Safety & Access Initiative of India Foundation & Consumer Online Foundation
Academic Perspective Dr Sujata Sawarkar – Professor in Pharmaceutics, Bhanuben Nanavati College of Pharmacy
12:45 pm -1:00 pm Q & A
1:00 pm - 2:00 pm LUNCH & NETWORKING
Session 4: Global PV Updates
2:00 pm - 2:30 pm Audits and Inspections Durga Mane - Senior Manager- Quality, Cognizant Technology Solutions
2:30 pm - 3:00 pm EU PV Updates Dr Manoj Swaminathan - Chief Manager / Head, Global Pharmacovigilance Center, Piramal Enterprises Limited
3:00 pm - 3:30 pm Risk Management Plan Dr Anand Harugeri - Associate Director, SARA, Marketed Product Safety Services, Lifecycle Safety, IQVIA
3:30 pm - 3:50 pm TEA BREAK
Session 5: Pharmacovigilance Guidance Document for MAHs of Pharmaceutical Products
Moderator: Dr P S Karthik Babu, Multi Country Safety Head, Sanofi
3:50 pm - 5:05 pm
IDMA Representative Dr R. K. Sanghavi - Sr. Consulting Clinician & Chairman - Medical Committee, Indian Drug Manufacturers' Association
RA Expert View Kedar Suvarnapathaki - Head, Regulatory Affairs & Intellectual Property - Boehringer Ingelheim
OPPI & EFPIA Representative Dr Jamal Baig - Global Safety Country Lead - MSD
CDSCO Representative CDSCO Representative Invited
PV Expert View Dr Deepa Arora - VP- PV & Global Head- Drug Safety & Risk Management, Lupin Limited
5:05 pm - 5:20 pm Q & A
5:20 pm - 5:30 pm Vote of Thanks Indu Nambiar - Co-Chair, ISCR Pharmacovigilance Council
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