DSS India – Drug Safety Symposium
Drug Safety Symposium
India Chapter

Dates to be announced
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.

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.

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.

Cutting-Edge Technology

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

Regulatory Insights

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

Past Speakers

President &
Chief Quality Officer,
Lupin

Dr. Ranjana Pathak

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

Dr. Somnath Basu

Head- Global Pharmacovigilance

Dr. Rahul Somani

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

Head-Pharmacovigilance · Emcure Pharmaceuticals

Dr. Neha Vala

Global Head - Pharmacovigilance, Cipla
Mr. Prasad Deshmukh

Executive Vice President - Medical Affairs

Dr. Rashmi Hegde

Director- Global Patient Safety & Pharmacovigilance,
Novartis

Mr. Mukesh Gori

Founder Director
Rhyme Life Sciences

Dr. Abhay Chimankar

Multi-Country Safety Head, Sanofi

Dr. Jamal Baig


Vice President, 3Analytics

Bhageswari Sreeraman

Past 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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Our Solutions
Pharmacovigilance:
– Safety Database: Solutions for Drugs, Devices, Vaccines, and Combinational Products.
– Literature Automation: Streamlined literature management.
– ICSR Submission Automation: Effortless case report submissions.
– Smart EV Triage Automation: Intelligent event triage.
– Signal Automation: Proactive safety signal management.
– Document Management: Handling of PADER, SDEA, and reports.
Clinical Research:
– Early & Late Phase Trials: Support for clinical trial management.
– Regulatory Services:
  – eCTD / CTD: Electronic and traditional submissions.
  – RIMS: Regulatory Information Management Systems.
Quality:
– Quality Processes: Enhancing quality management.
– Document Management: Managing SOPs, Protocols, etc.
– Training Management: Comprehensive training solutions.
 Consulting:
– Advanced Analytics: Strategic data insights.
– Digital Bots: Task automation.
– AI/ML Automations: Innovative AI and machine learning solutions.

With a global user base of 75,000+ in over 50 countries, Sarjen Systems is a trusted partner for digital transformation. Let us help you drive business efficiency with technology.

Learn More

“ Vizen Life Sciences is a global leader in delivering comprehensive End-to-End Pharmacovigilance and Regulatory services. Our team of highly qualified medical professionals, including physicians and pharmacists, provides full vigilance support for a wide range of products, from generics to innovators and advanced therapies. Our services encompass medical information call centres, ICSR processing and reporting, global medical literature monitoring, aggregate report writing, risk management, signal detection, HHE reports, safety data exchange agreements, legacy data migration, and QPPV services for the EU, UK, Australia, Vietnam, Africa, and GCC countries.

What sets us apart is our ability to provide cost-effective, end-to-end PV, Regulatory, and QPPV services on a single platform, integrating enterprise-specific safety databases, MICC case-intake tools, digitized QMS, and training from Caliber Learn IQ tool. This seamless integration ensures efficient PV processes and exceptional client satisfaction.

Our pharmaceutical clients benefit from our high-quality pharmacovigilance services, delivered with a focus on compliance and customer satisfaction. We have also developed an in-house AI tool for rapid daily literature searches across therapeutic areas and fully digitized our Quality Management Systems.

At Vizen Life Sciences, we prioritize quality-driven, cost-effective solutions for global pre- and post- approval pharmacovigilance and related product safety services. With strategic locations in India and European global hubs, we offer extensive support and regulatory compliance, including GMP and GCP audits, certifications, and regulatory dossier preparations.

Contact us today to learn how we can support your global pharmacovigilance needs.”

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SESSION PARTNER

Rhyme Life Sciences Private Limited(RLS) is established in 2017 with the determination and commitment to offer the Pharmaceutical industry with the solutions which are innovative, and compliance driven thereby meeting the regulatory expectations. We committed to deliver accurate, timely and cost-effective services throughout the regulated markets. We are team comprising of experienced professional including physicians, pharmacists, life science graduates and post graduates. Team is well acquainted with the regulatory needs including but not limited to USFDA, EMA, TGA, CDSCO and others. We are assertive and confident to have ‘know how’ We are proud to highlight our expertise in handling USFDA and MHRA inspections.

Our services:
1. Literature monitoring: Literature screening, Follow up of lit. reports, screening of non-valid articles, signal report based on non-valid articles
2. Review of MLM source data, xml file(including acceptance and/or rejection)
3. Case processing: Mailbox handling, book-in/log in, triage, data entry, quality review, medical review, case lock, case submission
4. Aggregate report: PSUR(R1), PBRER (R2), PADER, India PBRER
5. RMP: EU RMP, Non EU RMP
6. Signal management: Including signal detection, signal evaluation, prioritising and drafting signal reports
7. Setting up PV system- This include PV policy, SOP preparation, resource estimate, mailbox, internal communication, formation of safety review committee
8. PSMF maintenance
9. SDEA management
10. HHE reports
11. Third party audit
12. Training to partners
13. SPC/PIL comparison
14. QPPV/local QPPV services
15. Preparation of DSUR
16. Consultation on MHRA, USFDA and other Regulatory Inspections. Rich experience in handling the inspections.

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3Analytics Inc., founded in January 2020 in Silicon Valley, CA, is dedicated to enhancing drug and vaccine safety through AI and global data aggregation. The company brings together passionate experts from multiple disciplines to save lives. 3Analytics has made significant strides, partnering with JHPIEGO, a Johns Hopkins Public Health affiliate, to blend pharmacovigilance with public health. Recognized for its innovative approach, 3Analytics has been shortlisted by the WHO for Active Vaccine Safety Surveillance and Cohort Event Monitoring, highlighting its commitment to advancing global health and safety.

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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 – 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 is a strategic investment, to explore sponsorship opportunities and discuss customized packages, please contact us at [email protected]

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Gateway of India 

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Marine Drive

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Haji Ali Dargah

Mount Mary Church

Elephanta Caves

 Kanheri Caves

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Dr. Ranjana Pathak

President & Chief Quality Officer, Lupin

Ranjana is a seasoned pharmaceutical professional with over three decades of global experience. Her expertise lies in quality and related functions, and she currently oversees Lupin’s global quality operations.
Before joining Lupin, Ranjana held the position of Global Head for Quality and Pharmacovigilance at Dr. Reddy’s. During her tenure, she was a key member of Dr. Reddy’s Management Council, contributing to several positive outcomes for the company.
Her leadership journey extends across various branded and generic pharmaceutical companies, including Cipla, Actavis, Endo, Zenith Goldline, and Thames Pharmacal.
Ranjana’s academic achievements include a Doctorate in Health Administration from the University of Phoenix, USA, an MBA from Dowling College, New York, a Post-Graduate Diploma in Pharmaceutical & Chemical Analysis from Sophia College, Mumbai, and a B.Sc. (Hons) in Chemistry from Mithibai College, Mumbai. Additionally, she has received specialized training in pharmaceutical and biologics leadership at Harvard University.

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.

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. 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.

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.

Mr. Mukesh Gori

Director – Global Patient Safety & Pharmacovigilance, Novartis

Mr. Mukesh Gori, with extensive experience in global patient safety and pharmacovigilance, serves as Director at Novartis. He excels in executing strategic visions, managing external relationships, and ensuring QMS compliance in supplier selection, qualification, and management. His responsibilities include overseeing contract management, third-party risk, governance, transitions, and budget planning for outsourcing. Mukesh facilitates leadership-level communication, providing strategic advice on Alliance operations and contributing to the Pharmacovigilance System Master File (PSMF).
He leads governance forums, manages issues, escalations, and transitions, and ensures adherence to global SOPs. Mukesh has created RFP documents, conducted vendor due diligence, and managed audits, CAPAs, and QMS processes. As a people manager, he emphasizes team retention, training, and diversity. Before Novartis, he led Operations and Vendor Management in Drug Safety at Cipla Pharma, overseeing biosimilar management and regulatory inspections.
Mukesh’s expertise in pharmacovigilance strategy and operations positions him as a leader committed to driving excellence, effective communication, and a culture of quality and compliance in all his professional endeavors.

Dr. Abhay Chimankar

Founder Director
Rhyme Life Sciences & Cadence Life Sciences

With over 20 years of experience, Dr. Chimankar is a global leader in drug safety and pharmacovigilance, he has extensive experience in medical writing, clinical trials, and auditing. Dr. Chimankar is well-versed in EU GVP modules and is known for his strategic planning and implementation skills, delivering business value through streamlined PV operations. He is a recognized pharmacovigilance auditor with experience in USFDA and MHRA inspections, conducting the highest number of audits during the pandemic. He is a respected national and international speaker, panelist, and moderator in pharmacovigilance conferences, and is one of the top PV consultants in India.

Dr. Jamal Baig, M. Pharm

Multi-Country Safety Head for South Asia & Indo-China Sanofi India

Dr. Jamal Baig, M. Pharm, Ph.D. (Pharmacology), is the Multi-Country Safety Head for South Asia & Indo-China at Sanofi India since November 2021, with over 16 years of experience. He previously served as the PV Head at MSD Pharmaceuticals for 11+ years and as a Team Leader at Pfizer Drug and Safety PV Process at Wipro Ltd. He has held various industry positions, including Chair of the PV Council at ISCR and member of the PV Task Force at OPPI. Dr. Baig has played a leading role in developing PV guidelines in India and is a frequent speaker at national and international PV events.

Bhageswari Sreeraman

Vice President – Products, 3Analytics

Bhageswari Sreeraman, Vice President at 3Analytics, is a primary subject matter expert in pharmacovigilance. With extensive experience in product development, business support, and customer requirement identification, she excels in PV and clinical trials, project and team management, and communication. Since June 2022, she has led 3Analytics in developing innovative solutions and supporting business development. Previously, she managed safety aspects and teams at ICON Clinical Research and TCS, demonstrating strong leadership and compliance management skills. Bhageswari holds an executive MBA from IIT Bombay and advanced certifications in drug safety and clinical trial management.