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Courtyard Marriott, Mumbai

Apr 03, 2020 8:00 AM - Apr 04, 2020 6:00 PM

Mumbai C.T.S. No. 215, Andheri Kurla Road, Andheri East 400 059, MH, India

DIA India 8th Pharmacovigilance Conference

At this event, DIA India brings together key regulatory authorities, leading industry subject matter experts and thought leaders for collaborative discussions on driving innovation in drug safety and pharmacovigilance.

Speakers

Moin  Don

Moin Don

Adjunct Prof Jamia Hamdard Delhi, Lead:South Asia Chapter (ISoP), International, Society of Pharmacovigilance (ISoP), Founder & CEO PVCON Consulting, , India

Moin is a veteran alumnus with 44 years of work in the Pharma Industry and still counting. He is one of the well-known Pharmacovigilance (PV) professionals in Asia-Pacific having rich hands-on experience of practically every facet of Industrial Pharmacovigilance. He founded PVCON which is a Consulting & Auditing Services firm. He has undergone extensive training in U.S., Germany, France and Singapore to master PV. He is a certified "Lead Auditor"and is closely associated with Govt. Of India's National Pharmacovigilance Program as Advisor and Trainer for DCGI & PVPI staff. Recently, he has been nominated by the International Society of PV to lead its South Asia chapter.

Krishna   Bahadursingh

Krishna Bahadursingh

Head of Patient Safety, Bristol Myers Squibb, Japan

Dr. Bahadursingh has been a co-chair of the DIA PV India conference for the past 5 years and brings more than 25 years of experience in Pharmacovigilance and Medical Affairs to the table. His well-recognized breadth of experience affords him a unique perspective and expertise in developing comprehensive solutions to the most pressing challenges in pharmacovigilance and drug safety. He joined the pharma industry from clinical practice, after which he was assigned multi-disciplinary leadership roles of increasing responsibility central to ensuring patient safety and regulatory compliance both regionally and globally first at Eisai, Co., Ltd.’s Tokyo headquarters then at MSD Japan, ArisGlobal LLC and Syneos.

Shirish Dattatraya Sherlekar, MD

Shirish Dattatraya Sherlekar, MD

Global Head Life Sciences Practice, Tata Consultancy Services, India

Ramandeep  Singh

Ramandeep Singh

Service Delivery Lead, Accenture Services Pvt. Ltd., India

J Vijay  Venkatraman, MD, MBA

J Vijay Venkatraman, MD, MBA

Managing Director and CEO, Oviya MedSafe, India

Dr J Vijay is the Founder, MD & CEO of Oviya MedSafe, a global Pharmacovigilance consulting & Drug Safety services providing company based in India and the United Kingdom. He is the first Indian to have received the Fellowship of the Pharmaceutical Information & Pharmacovigilance Association (PIPA), UK. He has been the India Regional Editor of Global Forum, a DIA publication, since 2017. He served as Chair of the Pharmacovigilance Council of the Indian Society for Clinical Research (ISCR) since the Council’s inception in 2015 until 2019. He was the Chairman of the Indian Medical Association (IMA) Headquarters Standing Committee for Pharmacovigilance for 2021. He is a recipient of IMA’s Leadership Excellence Award.

Prashant  Joshi, RPh

Prashant Joshi, RPh

Executive Director - Drug Safety, Labcorp Drug Development, India

Pharmacist with over 22 years of experience in pharma industry with over 14 years in end to end patient safety experience, including ICSR management, safety and risk management, Database implementation and migrations.Worked across entire safety service lines. Managed Delivery, quality, compliance and transitions for multiple projects across various therapeutic areas including Oncology, Orphan drugs, Biologics (Vaccines and other biologics), generics and innovator products. Managed communications with regulatory agencies, hands on experience managing multiple regulatory inspections like with MHRA, EMA, FDA etc. Experience managing electronic submission gateways, EudraVigilance, xEVMPD etc. Experience overseeing QPPVs and local RPs.

Milind  Sardesai

Milind Sardesai

GM - Medical Safety Services, Cognizant Technology Solutions India, India

Emmanuel  Belabe

Emmanuel Belabe

Vice President, Global Commercial Organization, ArisGlobal, United States

Emmanuel Belabe, better known as “Manny”, has worked within ArisGlobal in a number of different roles over his 15 years with the company. During that time, he developed an approach that sought to educate clients on best practices for leveraging ArisGlobal products, while advocating on the best way to deliver additional value through the implementation of additional ArisGlobal solutions. This led to his current role of Product Owner for Safety Solutions, where he will be responsible for implementing tightly integrated tools that fit within the company’s vision of providing a unified platform across all R&D domains.

Avinash  Kakade

Avinash Kakade

Vice President and Head of Pharmacovigilance , Cipla, India

Dr Avinash is currently the Vice President and head of global pharmacovigilance at Cipla. He has 20 plus years of total experience. He has worked with innovator and generic pharmaceutical companies as well as with pharmacovigilance service providers enabling him to have a holistic view of the PV operations.

Niranjan  Kulkarni

Niranjan Kulkarni

Manager, Cognizant Technology Solutions India Pvt. Ltd., India

Mangesh  Kulkarni, MD

Mangesh Kulkarni, MD

Global Drug Safety - Physician and Head of Practice, Tata Consultancy Services, India

Dr Mangesh is MD physician with over 14 years of experience in Clinical Drug Development, Pharmacovigilance and Medical Affairs from diverse set-ups such as Academia, Contract Research Organization (CRO), Pharmaceutical and IT Industry. In his current role as Head of Safety Operations in the Drug Safety & Epidemiology at Novartis Healthcare Pvt Limited, Hyderabad, he is responsible for global ICSRs and Aggregate safety report submissions

Gurpreet  Singh, RPh, PMP

Gurpreet Singh, RPh, PMP

Senior Director- Pharmacovigilance , PAREXEL, India

Felix  Arellano, MD, PhD, FISPE

Felix Arellano, MD, PhD, FISPE

Global Head Safety Risk Management, Hoffmann-La Roche Limited, Switzerland

A graduate in medicine from Universidad Autonóma de Madrid, Spain, postgraduate studies in pharmacoepidemiology at Macgill University, Montreal, Canada and in pharmaceutical medicine (combined Strasbourg, Basel and Freiburg universities) Dr Arellano has more than 20 years of experience in the safety and pharmacovigilance (PV) field in the pharmaceutical industry. A senior executive having worked in global roles for top 10 pharma in PV of medicines, consumer products, devices and vaccines Dr Arellano is Global Head of Safety Risk Management at F Hoffmann La Roche, Switzerland. With a career spanning all elements of PV Dr Arellano is committed to excellence in medical compliance and innovation in safety science to create value for society.

Gerald  Dal Pan, MD, MHS

Gerald Dal Pan, MD, MHS

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States

Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. In this capacity, he is involved in both the premarket and postmarket regulation of drugs and therapeutic biologics, and in the implementation of the drug safety provisions of the Food and Drug Administration Amendments Act and other initiatives.

E. Stewart  Geary, MD

E. Stewart Geary, MD

Senior Vice President, Eisai Co., Ltd., Japan

E. Stewart Geary, MD, is Global Safety Officer at Eisai Co., Ltd. He is a Councilor of the Japanese Association of Pharmaceutical Medicine and serves on the Editorial Advisory Board for the Journal of Pharmaceutical Medicine. A member of CIOMS XII, he also served on the CIOMS VII Working Group on the Development Safety Update Report, CIOMS VIII on Signal Detection, CIOMS on Standardized MedDRA Queries, CIOMS IX on Medicinal Product Risk Management and CIOMS Working Group on Drug-Induced Liver Injury. Dr. Geary is a DIA Fellow, a Fellow of the Academy of Physicians in Clinical Research and an IFAPP Global Fellow in Medicines Development. He earned a BA from Harvard and MD from Stanford Medical School.

Pankaj  Sachdeva

Pankaj Sachdeva

General Manager, SpringerNature Technology and Publishing Solutions,, India

Raj  Bhogal

Raj Bhogal

Senior Director, R&D Audits & Inspections, Jazz Pharmaceuticals, United Kingdom

MSc Qualified Quality professional graduate with BSc in Pharmaceuticals Sciences from Kingston University and MSc in PV and Pharmacoepidemiology from the EU2P (Consortium of EU universities).I joined Jazz during the lockdown period in the UK to head the R&D Audits and Inspections team in July 2020. My team is global supporting the Early Development, Clinical and PV system related Audit & Inspection activities reporting into Global Quality. I have been in the pharmaceutical industry for 20+ years. I started my career on a manufacturing plant working on process development, optimization and validation at Eli Lilly & Co and then moved into more R&D quality operation roles at Shire (now known as Takeda).

Madhur  Garg, MBA, MS

Madhur Garg, MBA, MS

Director, Real World Evidence and Market Access, Labcorp Drug Development, United States

Madhur is Director of Real World Evidence and Market Access at Labcorp Drug Development.He has worked across global and regional roles in the pharmaceutical industry. He is a market access and pricing strategist with health economics and outcomes research background. His career has spanned across Europe and Asia working for various life science companies (including J&J, Lundbeck & LEO Pharma). He possesses experience with all major payers and health technology assessment (HTA) bodies across Europe, North America, Middle East and Asia Pacific.

Madhur  Gupta

Madhur Gupta

Technical Officer - Pharmaceuticals, WHO, India

Rie  Matsui, RPh

Rie Matsui, RPh

Senior Director, Regional Labeling Head for APAC, International Labeling, Pfizer R&D Japan G.K., Japan

Rie Matsui is Senior Director, Regional Labeling Head for APAC, International Labeling Group, Global Regulatory Science, Pfizer Japan. She is also the Head, External Engagements for ILG. She is the founder of Asia Labeling Hub at Pfizer that has created various local label updates for more than 25 countries in Asia. She was a member of the Advisory Council of DIA Japan until 2020 and received the DIA Japan regional award in 2015. Her papers were published in scientific journals such as Therapeutic Innovation & Regulatory Science. She is the vice chair of the 2021 DIA Japan Annual Meeting Program Committee. She received DIA Global Inspire Award Connector in 2022. She is teaching at Keio University and Chiba University and is a pharmacist.

Ramprasad  Polana

Ramprasad Polana

, India

Manoj  Swaminathan

Manoj Swaminathan

Chief Manager / Head Global Pharmacovigilance Center, Piramal Enterprises Ltd, India

Anju  Agarwal

Anju Agarwal

Head of Drug Safety, Advanz Pharma, United Kingdom

Sarath  Mundra

Sarath Mundra

Global Labelling Product Lead (Janssen), Tata Consultancy Services, India

Humaira   Qureshi

Humaira Qureshi

President , Qinecsa Solutions, United Kingdom

Rubina  Bose

Rubina Bose

Deputy Drugs Controller (India), CDSCO (West Zone), India

Dr. Rubina has regulatory experience of more than 21 years, working in Central Drugs Standard Control Organisation (CDSCO), the National Regulatory Authority of India in various capacities as head of zones , head of division of import registration, new drug, quality assurance of vaccines . She started her career in CDSCO as Drugs inspectors conducting GMP, GCP, GLP inspections.She has five years experience of working in production of Injectable drugs prior to joining CDSCO. Presently working in CDSCO (HQ), New Delhi looking after International Co-operation and prior to this she was working as zonal head, Deputy Drugs Controller (I) in CDSCO (West Zone) comprising of the states of Maharastra, Goa, Daman, Silvassa, DNH and Chattisgarh.

Seema  Gurbani

Seema Gurbani

Offering Lead- Medical Writing and Medical Affairs, LifeSciences- North America , Tata Consultancy Services Limited, India

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