DSS India – Drug Safety Symposium
Drug Safety Symposium 2024
India Chapter

June 28th – 27th, 2024
Unity in Safety: Elevating Indian Pharmacovigilance to Global Excellence

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Enhancing Quality Assurance

At Drug Safety Symposium 2024, we are at the forefront of ensuring drug safety through the rigorous practices of pharmacovigilance, regulatory compliance, and quality assurance. Our premier gathering provides a dynamic platform where attendees can explore the latest industry trends, stay updated on regulatory changes, and discover innovative solutions that drive the pharmaceutical industry forward. We are committed to excellence and facilitating meaningful discussions, knowledge sharing, and collaboration.

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Why Drug Safety Matters

In an ever-evolving pharmaceutical landscape, the importance of drug safety cannot be overstated. Each day, countless lives depend on the efficacy and safety of pharmaceutical products. Our mission is to advance the critical mission of ensuring that every drug is not only effective but also safe for consumption.

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A Uniquely Engaging Event

What sets Drug Safety Symposium 2024 apart is our unique approach. We combine insightful knowledge sharing with interactive workshops and networking opportunities, all in an atmosphere of camaraderie and fun. It's not just an event; it's an experience that empowers you to make informed decisions and contribute to the highest standards of drug safety and quality.

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Our Commitment

Your perception is our reality, that’s what makes us different! Here’s what we do to deliver exceptional content.
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Global Thought Leadership

Our conference brings together the leading experts, thought leaders and regulators to provide unparalleled insights into the latest trends and challenges shaping the industry.
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Interactive Learning

Our unique approach ensures a holistic and engaging experience for our attendees. Our conferences are not just about passive listening; it's about active participation. Gain practical insights and actionable takeaways that you can apply immediately in your role.
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Cutting-Edge Technology

Explore the latest technological advancements and software solutions that are transforming pharmacovigilance practices, offering efficiency and compliance.
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Regulatory Insights

Gain direct access to regulatory authorities and compliance experts who provide valuable insights into regional and international pharmacovigilance regulations.

Speakers

SCIENTIST-E in QMS & REGULATORY, AMTZ, Vizag
(Former Drug Controller of India)

Dr. Somnath Basu

Head- Global Pharmacovigilance

Dr. Rahul Somani

Head-Pharmacovigilance · Emcure Pharmaceuticals

Dr. Neha Vala

Vice President – Pharmacovigilance and Medico-regulatory affairs at Ipca Laboratories Ltd.

Geeta Shanbhag

Vice President & Global Head – Pharmacovigilance, Glenmark Pharmaceuticals

Mr. Rajendra Kasi

Dy. QPPV (Asst GM) - Clinical Research & PV,
Serum Institute of India
Mr. Chetanraj Bhamare

Associate Vice President and Head of Global Medical Writing, Viatris

Dr. Aswin Kumar

Head Global Pharmacovigilance, Zydus Lifesciences

Dr. Devang Patel

Director- Global Patient Safety & Pharmacovigilance,
Novartis

Mr. Mukesh Gori

Global Head - Pharmacovigilance, Cipla
Mr. Prasad Deshmukh

Executive Vice President - Medical Affairs

Dr. Rashmi Hegde

Multi-Country Safety Head, Sanofi

Dr. Jamal Baig

Event Partners

Exhibit Partner

Techsol Life Sciences is an integrated PV business solutions provider for global pharma and medtech companies. Our unique PV PIVOT solution focuses on delivering high-quality and regulatory compliant pharmacovigilance and medical communications functional services using a powerful combination of subject matter experts, PV domain knowledge, lean business processes, cost-effective service models coupled with modern technology.

Our next-generation solution framework allows clients to leverage our purpose-built PV Ops platform to digitalize, automate and perform real-time oversight of Intake, ICSR Operations, Quality Assurance, Agreements Management, Aggregate Reporting, Literature Monitoring, PSMF Management, and significantly increase quality, compliance, and productivity of PV & MICC operations. With our Oracle Argus Safety, E2B Gateway, and Empirica Signal expertise, we are known for safety system implementation, migration, validation, integration, reporting, application support, and change management to orchestrate regulatory compliant drug safety operations.
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PRICING

INR 40000*

+ 18% GST applicable

USD 1200*

+ 18% GST applicable

* Pricing is applicable for Pharma Manufacturing companies only.

Partners

Why Partner at Drug Safety Symposium 2024 – India Chapter?

By partnering with us, you can position your brand at the forefront of the pharmaceutical landscape and gain invaluable exposure to a highly targeted and influential audience.

Partnering with the Drug Safety Symposium 2024 is a strategic investment, to explore sponsorship opportunities and discuss customized packages, please contact us at [email protected]

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Dr. Somnath Basu

SCIENTIST-E in QMS & REGULATORY, AMTZ, Vizag
(Former Drug Controller of India)

With a robust academic background in Chemistry (Honors) and Biochemistry (Masters) encompassing Molecular Biology, Microbiology, and Genetics, Dr. Basu earned his Ph.D. from Calcutta University. His professional journey began at CDL-Calcutta, a WHO collaborating center and National Appellate lab for drug analysis, where he acquired over 6 years of expertise in analytical techniques such as HPLC, GC, IR, and Microbial Assay.
Currently, serving as a Scientist-E at AMTZ, Vizag, specializing in Quality Management Systems and Regulatory affairs. In his previous role at CDSCO, he led a team of reviewers for the regulation of new drugs, recombinant drugs, vaccines, stem cell therapeutics, medical devices, and in-vitro diagnostics. He also served as the focal person for WHO-NRA assessments since 2007, contributing to the strengthening of the Indian Drug Regulatory Authority.
Throughout his career, he has collaborated with various departments and organizations, including the Ministry of Health, Ministry of Revenue, Ministry of Agriculture, QCI, BIS, NIB, IPC, PvPI, AEFI Secretariat, Immunization Division of GoI, CDL (Kasauli), DBT, THSTI/CDSA, and the Department of Animal Husbandry.

Dr. Rahul Somani

Global Head – PV, Alkem Laboratories

I have been with Alkem Laboratories Ltd, Mumbai, for the past 13 years in various roles and am currently serving as the Head of Global Pharmacovigilance.
With 25 years of experience spanning both academic and industrial roles, I have played a key role in establishing an in-house Pharmacovigilance department that adheres to stringent regulatory standards and processes. This has supported our global pharmacovigilance operations through the development and implementation of comprehensive safety monitoring systems, risk management plans, and regulatory compliance strategies.
In the past five years, I have successfully led my team through three major regulatory inspections for Pharmacovigilance by the USFDA, TGA-Australia, and MoH-Kazakhstan. These inspections required meticulous preparation and a deep understanding of regulatory requirements, affirming the robustness and effectiveness of our pharmacovigilance practice.

Dr. Neha Vala

Head-Pharmacovigilance · Emcure Pharmaceuticals

Dr. Neha Vala is a seasoned medical professional (M.B.B.S) with approximately 17 years of experience in pharmacovigilance, clinical research, and medical domains.
She has an extensive training in basic and clinical pharmacology, global pharmacovigilance guidelines, MedDRA, and GCP. She possesses comprehensive knowledge of global pharmacovigilance requirements with expertise in risk management planning, signal management, and periodic risk-benefit evaluation.
With a proven track record of establishing pharmacovigilance functions/units for various pharmaceutical companies, Dr. Neha is experienced in managing multiple regulatory inspections, including those by MHRA, US FDA, Health Canada, and other EU authorities, as well as conducting numerous client audits.
She is a recognized speaker at numerous national and international pharmacovigilance conferences.

Geeta Shanbhag

Vice President – Pharmacovigilance and Medico-regulatory affairs at Ipca Laboratories Ltd.

Currently, Geeta Shanbhag is working as Vice President – Pharmacovigilance and Medico-regulatory affairs at Ipca Laboratories Ltd.
A management post graduate with pharmacy background, she has around three decades of experience in pharmaceutical industry, inclusive of medico-marketing, regulatory affairs, clinical research, bioequivalence studies, pre-clinical studies and pharmacovigilance.
She is a proactive team player with strong planning skills, critical/ analytical thinking, multitasking, problem solving, and team management skills.
From past 15 years, she is involved in pharmacovigilance. She has been instrumental in setting up in house pharmacovigilance department in Ipca, which handles end to end pharmacovigilance on global scale. She has also initiated automation of various pharmacovigilance related processes such as auto-labelling, auto-narratives, learning management system, electronic document management system, quality management system, medical inquiry system and android mobile application for adverse event reporting.
She has hands on experience on both Aris G and Argus database, data migration, case processing, medical writing in pharmacovigilance, vendor management, safety data exchange agreements, Trackwise software for Quality Management System, audits and inspections. In fact, Ipca successfully cleared its first US FDA pharmacovigilance inspection in 2017.

Mr. Rajendra Kasi

Vice President & Global Head – Pharmacovigilance, Glenmark Pharmaceuticals

Rajendra Kasi is a healthcare professional with more than 2 decades of experience in clinical and drug safety arenas. He is the Vice-president and Global Head of Pharmacovigilance at Glenmark Pharmaceuticals Ltd. Before joining Glenmark, he worked with reputed pharmaceutical companies like Zydus Cadila and Mylan Laboratories, etc. He played a pivotal role in establishing Pharmacovigilance units from scratch to hatch level for major pharmaceutical players in India. He believes quality consciousness, keeping oneself up-to-date with the latest happenings in the industry, and embracing and adopting new technologies in the domain are the key factors to ensure regulatory compliance.

Dr. Chetanraj G Bhamare

Dy. QPPV (Asst GM) - Clinical Research & PV,
Serum Institute of India

Dr. Chetanraj G Bhamare, is a Clinical Pharmacologist with over 13 years of experience in clinical research and pharmacovigilance. He has an MBBS and post-graduation – MD in Clinical Pharmacology and Therapeutics. Currently, he is working in the world’s largest manufacturer of vaccines, Serum Institute of India Pvt. Ltd. (SIIPL), Pune in the capacity of Safety Physician.
Since 2015, he has been working with Serum Institute of India Pvt Ltd and involved in end-to-end pharmacovigilance activities of all vaccines, biologicals, and clinical development.
He has many national and international publications to add to his credit. He is a member of the Indian Society for Clinical Research (ISCR) Pharmacovigilance Council and of the Developing Countries Vaccine Manufacturers Network (DCVMN) Pharmacovigilance Working Group.

Dr. Aswin Kumar

Associate Vice President and Head of Global Medical Writing, Viatris

Dr Aswin Kumar is a medical graduate (MBBS) from the prestigious MKCG Medical College in Odisha. Following this he joined Reliance for the Young Clinical Professional Program.
He has taken up positions of increased importance in CROs and BPOs like Lambda, Accenture, and Freyr Solutions. His notable pharma experiences include Hospira (now Pfizer), and for the last 7 years, he has been with Viatris, serving as Associate Vice President and Head of Global Medical Writing.
His work span includes Regulatory writing, Scientific Publications, Device Reports, Value Dossiers, and Publishing in Novel drugs, Biosimilars, and Generics.
He has additional qualifications in Pharmaceutical Medicine, International Business, Healthcare Management, and Six Sigma.

Dr. Devang Patel

Head Global Pharmacovigilance, Zydus Lifesciences

Dr. Devang Patel is a seasoned pharmacologist with over 17 years of experience in the field of pharmacovigilance (PV), showcasing a consistent record of achievements. He currently serves as the Head of Global Pharmacovigilance at Zydus Lifesciences, where he leverages his extensive expertise to ensure the safety and efficacy of pharmaceutical products worldwide.
Dr. Patel possesses a comprehensive understanding of global regulatory requirements related to pharmacovigilance. His in-depth knowledge spans major regulatory authorities, including the US FDA, EMA, MHRA, and various European national health authorities. This expertise has been instrumental in navigating complex regulatory landscapes and ensuring compliance with stringent standards.
Dr. Patel is also a seasoned pharmacovigilance auditor, having conducted onsite audits in the UK, Russia, and Hong Kong, as well as remote audits for Turkey. His auditing skills have been crucial in identifying potential issues and ensuring that organizations maintain high standards of drug safety and regulatory adherence.
Dr. Patel’s extensive experience includes close collaboration with global regulatory authorities for a wide range of molecules, including New Chemical Entities (NCEs), vaccines, biologics, and chemical molecules. His ability to effectively communicate and work with these authorities has facilitated the smooth progression of numerous drug safety programs.

Dr. Prasad Deshmukh

Vice President, Head Pharmacovigilance, Cipla Ltd.

A PV and Project Mgt Professional with more than 20 years of experience, Dr. Prasad leads the Global PV operations at Cipla. He has experience in clinical practice and pharmacovigilance working with BPO, CRO, and pharmaceutical companies.
His expertise includes working with global companies across multiple regions, including Japan & China. He has worked with various cross-functional teams during his career to establish and successfully deliver PV projects. His Passion includes learning and Coaching. He also likes to read and follow sports during his leisure time.

Dr. Rashmi Hegde

Executive Vice President - Medical Affairs

Rashmi Hegde is a Pediatrician by training and has been associated for over 3 decades with global Pharmaceutical companies – Abbott, Novartis, Solvay and Cipla.
Rashmi has been in her current role as CMD & Executive Vice President GSK India since 2021. She leads Medical Affairs, Medical Science Liaison, Medical Operations, Governance, Excellence, Drug Safety, Patient Affairs & Clinical Studies.
In her previous role as Vice President Cipla Ltd; Rashmi and her team of 70+ Medical Professionals led Medical Affairs for the USD 2 billion India Business for Arrow Head Brands in Respiratory, Gastroenterology, Oncology and Cardiometabolic Therapies.
As Abbott Ltd., Medical Director, she has worked for over a decade in India and Asia-Pacific countries with Vaccines, Gastroenterology, Womens Health and Neurosciences Therapies. She led the Abbott PV Regional Team for 33 Affiliates in the Emerging Markets, Australia and Canada for 5 years.
Rashmi takes a keen interest in Pharmaceutical laws, Safety Regulations, Health Technology, and Precision Medicine and its impact on Patient Outcomes. She explores the latest use of Artificial Intelligence, Big Data and Real World Evidence and its applications to Clinical Studies and New Product Development.
She is a prolific speaker at International scientific forums and has published several scientific papers.  She relaxes with Hindustani Classical Music, early 19th century English authors and with her family.