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Novotel Mumbai Juhu Beach

2024年9月24日 (火) 午前 8:00 - 2024年9月25日 (水) 午後 6:00

Balraj Sahni Marg, Juhu Beach, Mumbai 400049, India

DIA India Annual Meeting 2024

Confluence of Care: Pharmacovigilance, Clinical Innovation, Regulatory Sciences, and Medical Devices Elevating Patient Safety

Early Bird ending in

DAYS

HOURS

MINUTES

SECONDS

スピーカー

Moin  Don

Moin Don

Founder and CEO, PVCON Consulting, Lead: South Asia Chapter, International Society of Pharmacovigilance (ISoP), 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.

Ashish  Indani

Ashish Indani

Senior Manager – Clinical Affairs Neurovascular, Stryker Global Technology Center, India

Ashish is Senior Manager at Stryker neurovascular and has over 21 years of Clinical Research and Digital Innovation experience in Medical Devices. As a principal scientist in TCS, He has been the part of world’s first Artificial Intelligence based pharmacovigilance processing system development and deployment. He has invented the Nano technology-oriented solution for breath-based detection of cancers and infections and has extended the technology for recreation of as auto adjusting mask, detection of pathogens on nonliving surfaces, circulating air and Sewage water. He has worked on Digital Heart, Digital Nose and AI based preclinical to clinical translation of medical device safety and performance data.

Fahd  Khan

Fahd Khan

Director Business Development , OrciMed Life Science Private Limited, India

Fahd is a seasoned marketing and business development professional with a wealth of experience spanning 16 years. Throughout his career, he has gained expertise in a variety of areas, including marketing strategy, sales, account management, pre-sales, and bid management. He has worked across a range of industries, including BPOs, pharmaceuticals, IT, life sciences, and healthcare, and has a proven track record of successfully managing businesses in a variety of regions, including Europe, North America, the Middle East, Asia Pacific, and Central Asia. Fahd is known for his strong communication skills and the ability to effectively lead a diverse team.

Prashant  Joshi, RPh

Prashant Joshi, RPh

Executive Director - Drug Safety, Fortrea, 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.

Ritu  Jaswal

Ritu Jaswal

Vice President - Pharmacovigilance Operations, Parexel, India

Ritu Jaswal Vice President- Pharmacovigilance Operations has experience of more than 18 years in Parexel. She practiced dentistry for 5 years before moving to the CRO world. Involved in winning and take off of more than 25 PV projects. Leading a team of over 2500 staff globally. GMBA for Mohali and Chandigarh offices for Parexel. She likes gardening, reading fiction, listening to music and cooking.

Saket  Singh Kumar, MSc

Saket Singh Kumar, MSc

Principal Director Global PV Capability Lead - Operations, Accenture, India

Saket Singh, Vice president Global Pharmacovigilance capability lead overseeing operation for India, APAC, Europe & LAtam with 15yrs of experience in clinical domain, vast experience of handling operations for CDM, SDTM & Core expertise in handling the Pharmacovigilance process across multiple pharmaceutical clients. Expertized skills in leading large sales pursuits, thought leadership, developing strategies for growth, managing cross functional strategies, Pharmacovigilance processes, Audits & Inspection management, process re-engineering, operational excellence Project, Six sigma black belt.

Sonica Sachdeva Batra, DrMed

Sonica Sachdeva Batra, DrMed

AVP & Head – Regulatory Solutions, Indegene, India

I am an MD physician by training, with 20 years of experience in drug development and medical and scientific affairs. I am presently AVP and Global Head for Medical Affairs and Regulatory at a global technology enabled healthcare solutions provider. I have led many successful global Regulatory Authority engagements across the globe, for developed as well as the Rest of the World- emerging/ developing countries, enabling clinical development plans, strategies, marketing authorisations and post approval compliances for various products including biosimilars. I have a keen interest and experience in enhancing medical value add and scientific information dissemination for medicinal products, in the peri approval and post approval space.

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.

Vijay  Bhargav

Vijay Bhargav

Vice President, Lifecycle Safety, IQVIA, India

AS VP – Life Cycle Safety, Vijay leads Global Safety Case Processing, Regulatory Reporting and Literature Screening services for IQVIA. Vijay brings broad service delivery experience in life cycle safety across Drugs, Vaccine, Device and Consumer products across end-to-end safety case processing and more recently established global capabilities to support COVID vaccine programs for two of the largest vaccine makers. An early adopter of technology; has successfully deployed multiple tools and BOTs to achieve tangible benefits and optimization in his role. Vijay has over 20 years of service delivery experience in the healthcare industry and is a regular presenter at conferences.

Swapnali  Raut

Swapnali Raut

Director, Clinical Operations, Global Monitoring and Site Engagement (GMASE), Global Clinical Operations Development – R&D, GSK, India

Pramod  Kashid

Pramod Kashid

CEO, Expecto Health Science, Singapore

Dr. Pramod Kashid is a distinguished professional in the global clinical research and drug development industry, renowned for his expertise in cardiovascular and oncology clinical development as well as adaptive trial design strategies. With a wealth of experience in leading and expanding CRO business in the APAC region, Dr. Kashid is driven by a deep passion for improving the lives of patients by expediting the drug development process and ensuring timely access to innovative therapies. His commitment to making a difference in the healthcare industry is unwavering, as he continues to strive towards making new treatments accessible to those in need.

Manjusha  Rajarshi

Manjusha Rajarshi

Founder Regulus Healthcare, Partner at roots-simplified Research and Consulting LLP, India

Dr. Manjusha Rajarshi has over 30 years in the Pharma industry. She holds an M.Pharm, Ph.D., Diplomas in IPR, and a PG Diploma in Health Promotion from PHFI, New Delhi. Starting as a management trainee at B. Braun, she advanced through Unichem, Aventis Pasteur, Bayer, and Servier India, specializing in regulatory affairs, clinical research, patents, and trademarks. Currently, she is a freelance consultant and runs REGULUS HEALTHCARE in Mumbai. She is also a Partner at Roots-simplified Research and Consulting LLP, focusing on health research programs, scientific content, and strategic consulting, with several original research papers to her credit.

Manish  Paliwal

Manish Paliwal

Director, Regulatory Affairs, Pfizer, Inc., India

Omprakash  Sadhwani

Omprakash Sadhwani

Ex-Joint Commissioner (HQ) and Drugs Controller, Maharashtra Food and Drug Administration, India

30 years of experience in enforcement of drug laws with expertise in detection and investigation of contravention cases. Best Drug Control Officer of India – All India Drug Control Officers’ Confederation – 2010. Gaurav Puraskar – Government of Maharashtra – 2008. Represented India in multiple national and international pharmaceutical forums. WHO GMP audits for 28 years and WHO GMP certificate audit review and Certification Authority for 8 years. As per WHO TRS 823-Issued more than 240 WHO GMP certificates to manufacturers and 140 loan licensees every 2 to 3 years. Issued more than ten thousand COPPs. Former Secretary of All India Drug Control Officers’ Confederation (AIDCOC).

Jayesh  Jani

Jayesh Jani

Strategic Medical Affairs and Professional Education Director, ConvaTec, India

Priyadarshini  Arambam

Priyadarshini Arambam

Academics & Research Department - Batra Hospital and Medical Research Centre, General Manager - Clinical Research Operations, India

Susan  Korah

Susan Korah

Head - Delivery, Digital Health and Wellness, Tata Consultancy Services, India

Susan is a Healthcare Professional with over 25 years of operational & strategic experience across the entire Clinical Development value chain and Healthcare ecosystem. She has worked across - pharmaceuticals, life sciences, and healthcare BPOs, and has a proven track record of successfully managing businesses in various geographies including Europe, North America and APAC regions. Susan has liaised with regulatory agencies and has hands-on experience in managing multiple regulatory inspections with MHRA, EMA and US FDA. Susan has Master’s Degree in Pharmacy , specialized in Clinical Pharmacology. She is a Certified -Six Sigma Black Belt and LEAN Professional and a certified Workplace COACH.

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