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:

info@iscr.org 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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