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Radisson Blu International Airport

May 25, 2023 9:00 AM - May 26, 2023 5:30 PM

Metro Station, Marol Maroshi Rd, near Marol, Bori Colony, Gamdevi, Marol,, Andheri East,, Mumbai 400059, MH, India

Re-designing and Transforming PV for Augmenting Patient Safety


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.

Ashish  Indani

Ashish Indani

Sr. Manager – Clinical Affairs , Stryker , 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, 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.

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

VP Global PV Capability Lead, 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

Associate Vice President, Global Delivery Head, 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.

Shobhit  Shrotriya, PMP

Shobhit Shrotriya, PMP

Managing Director, Life Sciences R&D Operations, India, Accenture, India

Shobhit Shrotriya is an experienced professional in Accenture’s Life Sciences R&D practice based out of Bangalore. He is an Engineer by training with a Masters in Industrial Management from Indian Institute of Technology (IIT) Kanpur. He is a Certified Six Sigma Black Belt and Project Management Professional (PMP). With 23+ years of work-experience, Shobhit has extensive experience in Operations Management, Project & Program Management, Process Excellence and Innovation. Shobhit is a Subject Matter Expert who contributes to the solution development, process re-engineering, and implementation of life sciences outsourcing service delivery.

Abhijit  Surwade

Abhijit Surwade

Global Pharmacovigilance Physician, Colgate-Palmolive, India

Dr. Abhijit Surwade is a MBBS physician always eager to learn more and has varied experience including clinical practice for 3 years in private and government institutions followed by 11 years in pharmacovigilance. He has been associated with TCS, ADVANZ pharma and Lupin. He is passionate about risk-benefit analysis, safety assessments and risk management activities. He is currently associated with Colgate-Palmolive as Manager for Global Pharmacovigilance, leading the India team and responsible for Pharmacovigilance and Cosmetovigilance activities accompanying the global team.

Gerald J. Dal Pan, MD, MHS

Gerald J. 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.

Prashant  Dhanavade

Prashant Dhanavade

Associate Director - Patient Safety Solutions, Fortrea Drug Development, India

Dr. Prashant is an Orthopedic surgeon with over 22 years of experience, including 14 years in Drug Safety and Risk Management, combined with clinical practice. He has expertise in end-to-end drug safety activities for global innovator and generic pharmaceutical companies and has successfully trained and mentored global delivery teams. His focus areas are signal detection and risk management for products in various life-cycle stages, biologicals, medical devices and integrating traditional medical review methods with newer technologies.

Brian  Edwards, DrMed

Brian Edwards, DrMed

Vice President, International Society of Pharmacovigilance, United Kingdom

After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining J&J as a deputy QPPV in 2005. In addition he is Director of ISoP Secretariat Ltd, ISoP Board Member and VP in the Alliance Clinical Research Excellence and Safety (ACRES) . He chairs the unique Pharmaceutical ergonomics & human Factors Group in the UK. After 14 years at NDA Regulatory Science Ltd, he has his own pharmacovigilance consultancy Husoteria Ltd

Jeyaseelan  Jeyaraj

Jeyaseelan Jeyaraj

Senior Director, Solutions Consulting, Asia Pacific, Oracle Health Sciences Global Business Unit, India

Jey is a recognized Digital Health Strategist on addressing the challenges facing the global Healthcare & Life Sciences industry and prospects for improving patient outcomes through better use of data and information. Jey brings his 20 plus years of broad consulting experience with Healthcare Providers, Public Health & Pharmaceutical R&D that spans biotech, pharma and CRO. He is the President of the Healthcare Information and Management Systems Society (HIMSS) India chapter. He was the member of the drafting committee for Digital Health Standards, National Accreditation Board for Hospitals & Healthcare Providers (NABH) in India.

Kanchan   Kanitkar

Kanchan Kanitkar

Sr. Manager and Literature SME - Patient Safety Solution, Labcorp Drug Development India Pvt Ltd. , India

Kanchan has 14+ Years of work experience across end-to-end case processing activities. She has Post graduate in Pharmacy (M.Pharm) with a Lean Six Sigma Green Belt. Majority of her work experience is in setting up literature processes from search string set-up till review/processing/submission including MLM. She has hands on experience on end to end case processing services from triage till submission for all type of cases including (clinical trial, spontaneous, literature, regulatory reports). She is well versed with Argus set-up/validation and testing and ICH, European, US, TGA and Health Canada regulations for pharmacovigilance. She is experienced in writing PSMF for clients with European presence.

Kedar  Mehta

Kedar Mehta

Associate Professor , Govt. Medical College Vadodara , India

Dr. Kedar Mehta has pursued MBBS and MD in Community Medicine from Government Medical College Baroda. He has more than 100 research publications in national & international peer-reviewed journals. He is the recipient of National Award for Excellence in Clinical Research(Early-Career Category) awarded by Indian Society of Clinical Research(ISCR) and has received many national awards for his research activities.

Sakshi  Rastogi

Sakshi Rastogi

Global Client Solutions Partner , Quantiphi, India

Dr Sakshi Rastogi has over 22 years of rich life Sciences and pharmaceutical industry experience in pharmacovigilance, medical affairs, operations, program management, presales and solutioning, analytics (Commercial & Safety), Artificial intelligence-automation and global business development. In her current role at Quantiphi Inc, she acts as a Global Client Solutions Partner and Heads Healthcare and Life Sciences Sales strategy by collaboratively with her teams on implementing Next-Gen Solutions in Clinical and Post-marketing processes. She is passionate about improving business value meter for clients and spearheads transformative solutions across industry verticals.

Arunima  Sen, MD

Arunima Sen, MD

Associate Vice President, Product Safety and Risk Management,, Viatris, India

Dr Arunima Sen is a Physician by qualification and for the last 17 years has worked in various fields of Pharmacovigilance and Safety writing. She currently is associated with Viatris Pharmaceuticals as Associate Vice President for their Product Safety and Risk Management team. Prior to this she has worked in various CROs and Pharmaceuticals including Bioclinica, MMS Holdings Inc and AstraZeneca Pharmaceuticals.

Renu  Sharma

Renu Sharma

Senior Director Pharmacovigilance Operations, Parexel, India

Renu Sharma is currently working as a Senior Director, Pharmacovigilance Operations at Parexel International Chandigarh, India. She is a dermatologist by qualification. She started her journey with this organization ~15 years back. She has a clinical background in the field of Dermatology but because of her interest in PV she got associated with this field. During her tenure, she has successfully worked with multiple pharma clients providing support as a medical professional and managing end-to-end PV processes and operations. She believes in the fact that working in the drug safety field is a huge responsibility and is an absolute commitment towards patient safety. She wants to contribute to this field in every possible way.

Mohammed  Sibgatullah

Mohammed Sibgatullah

Director -Medical Affairs , OrciMed Life Science Private Limited, India

Dr. Mohammed Sibgatullah is a highly experienced physician with an MBBS and MD in pharmacology. He has over 11 years of industry and clinical experience and currently serves as the Director of Medical Affairs at OrciMed Life Sciences. In this role, he is responsible for leading the medical team and operations, implementing strategies for cost-effective and high-quality deliverables, expanding the business to include verticals that require medical expertise, and engaging with customers. He is a subject matter expert in various areas, including medical review, literature surveillance, risk management plans, core data sheet updates, and medical writing.

Niraj  Vyas

Niraj Vyas

Director Risk Management & Central Monitoring, The Janssen Pharmaceutical Companies of Johnson & Johnson, India

Niraj Vyas is Director in Risk Management and Central Monitoring at Janssen. He has 20+ years of experience across centralized monitoring, clinical operations, consulting, cardiac safety, and digital platform solutions. Prior to Janssen he was at IQVIA and TCS. Niraj is an MBBS and MBA.

Anu  Acharya

Anu Acharya

CEO,, India

Anu Acharya is a serial entrepreneur, columnist, poet, and a charismatic speaker. As the Founder & CEO of Mapmygenome, she introduced the concept of personal genomics in India with the launch of Genomepatri in 2013. She co-founded and pioneered her first venture Ocimum Biosolutions from 2000 to 2013 through innovative bioinformatics and LIMS solutions, global acquisitions, awards, and fund raises. She serves on governing boards of NIBMG; IIIT Hyderabad and WeHub; Advisory board at Action For India & KIIT; Board of mentors for Ivy Cap Ventures; member of CII National Committee on Biotechnology; Committee Member of HIMSS Asia Pacific India Chapter; NASSCOM Executive Council Member;

Vaibhav  Budhiraja

Vaibhav Budhiraja

Senior Manager - PV Operations, Paraxel, India

Vaibhav Budhiraja, born and brought up in Delhi, currently based out in Chandigarh, proudly working as a Senior Manager Pharmacovigilance Operations at Parexel. Associated with Parexel for close to 10 years now. Supervising team size of approx 200 safety professionals providing PV services to one of a major European pharma client. He is a Pharmacist by qualification, having a total work experience of 13 years, expert in ICSR case management activities, local PV support – ranging from case intake till case submissions to health authorities and literature management activities. Won outstanding performance awards in various years within the organization.

Bobby  George, PhD

Bobby George, PhD

Vice President & Group Head Regulatory Affairs, Reliance Life Sciences, India

Dr. Bobby George is Vice President & Group Head of Regulatory Affairs at Reliance Life Sciences, Mumbai. He holds Masters and Ph.D. in Pharmacology from Panjab University, Chandigarh. He has also completed Senior Management Program from IIM, Kozhikode. He has over 25 years of industrial experience. He has been with Reliance Life Sciences for over 2 decades now. At Reliance, he is responsible for all their regulatory services across Pharmaceuticals, Biosimilars, Blood products and Vaccines in both domestic and export markets. He has to his credit several publications including a book which he authored on healthcare laws and reforms called “The Act that Wasn’t”.

Mukesh  Gori

Mukesh Gori

Director –CMO&IPS, Global External Service Partner Engagement,, Pharmacovigilance & Safety Alliance Operations, Novartis, India

~17 years of experience, Physician in alternate medicine by training. Significant experience with increasing responsibilities, managing large multi-dimensional PV teams focusing on end to end value chain, global business outsourcing and procurement within Service industry, Domestic & International Pharma companies. Currently based out of India and supporting Novartis Global External Service Provider Engagement team.

Shadab  Makhdoomi

Shadab Makhdoomi

Associate Vice President, Accenture Life Sciences, India

I, Shadab am working as an Associate Vice President at Accenture Life Sciences R&D Operations within the Pharmacovigilance domain having close to 15 years of industry rich experience and helped multiple Europe and US based pharmaceutical companies in carrying out their Pharmacovigilance services with core expertise in Operational Management, Strategic Management, Stakeholder Management, Resource Management and Automation. By qualification, I have successfully completed my Bachelors in Dentistry with a Post Graduate diploma in Clinical Research. The most exciting part about my job is that is seamlessly aligns to my mission of making this world a better and safer place to live.

Pravin  Patil

Pravin Patil

Manger, PRMW, Global Pharmacovigilance, Innovation & Development Established, Pharmaceuticals, Abbott Healthcare Pvt Ltd, India

I am Dr. Pravin Patil having 14 years of experience in the field of Pharmacovigilance and clinical trials. I have completed my M.S. in Pharmaceutical Medicine. Currently I am working as a manager periodic reporting and MW at Abbott since July 2017. Before that I was working as an assistant manager at Tata consultancy services in ICSR and Medical writing for 6 years. I started my career in 2009 as a sub investigator in pediatric vaccine trials at KEM hospital Pune.

Geethashree  Shambu

Geethashree Shambu

Delivery Lead - Safety Operations, Indegene Pvt Ltd, India

Dr Geethashree, a dentist by training has over 20 years of experience, mainly comprising of clinical dentistry, academics, medical assessment, team lead and a certified PV trainer, managed medical writing and device portfolio, currently managing multiple PV engagements.

Shatrunajay  Shukla

Shatrunajay Shukla

Scientific Assistant MvPI , Indian Pharmacopoeia Commission, India

Dr Shukla has completed his M.S (Pharm) from NIPER-K in 2011 & earned his doctorate in Toxicology from CSIR-Indian Institute of Toxicology, Lucknow in 2016. He joined IPC in early 2017 and associated with the MvPI since 2018. He is currently working towards ensuring safe use of medical device in Indian population and development of a robust safety surveillance system for medical devices and IVDs. He has organized numerous national and international level training programmes for the professionals of medical device industries, healthcare professionals and regulatory authorities to enhance the knowledge, practice and compliance to the safety of medical devices and IVDs.

Thirumalai Velu   Swaminathan

Thirumalai Velu Swaminathan

Director, India & South Asia-Regulatory Affairs & Pharmacovigilance , Galderma India PVt Limited, India

Dr. Velu is a Physician by qualification with versatile experience in Regulatory affairs, Clinical Research, Medical & Pharmacovigilance. Soon after his post-graduation from Christian Medical College, Vellore, he was working at the Dept of Clinical pharmacology, wherein he was involved in teaching as well as Therapeutic Drug Monitoring and was part of a WHO project on Injection patterns in India. Later he moved to pharmaceutical industry and joined Torrent Research Centre, wherein he was leading a team of clinical research and was involved in several Phase 3 & BE studies. He was instrumental in setting up the PV operation for US arm of the company. In Torrent, he has faces successful USFDA & ANVISA audits.

Sanjay  Vyas

Sanjay Vyas

Executive Vice President, India Country Head & Managing Director, Global SBU , Head - Safety Services & Logistics, Parexel , India

Sanjay moved in 2019 to India from USA as the EVP, India Country Head & Board of Director, he is responsible to develop strategic direction & provide the leadership and vision necessary to grow the 6,000 plus India organization. He also is the Parexel’s Global Head of Safety Business Unit and Clinical supplies & Logistics business which also includes the global distributions centers & infrastructure. He lived & worked in 8 countries & 4 continents, Sanjay brings over +23 years of experience in Global P&L management, Logistics & Supply chain management, Sales & Marketing, M&A's, Operations & People management.

Chetanraj  Bhamare

Chetanraj Bhamare

Safety Physician (Asst. General Manager), Clinical research , and pharmacovigilance dept., Serum Institute of India Pvt Ltd, India

Dr. Chetanraj G Bhamare, is a Clinical Pharmacologist with more than 10 years of experience in the field of clinical research and pharmacovigilance. He did his graduation as MBBS and post-graduation as MD in Clinical Pharmacology and Therapeutics from Govt. Medical College in Maharashtra, India. 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 is working with Serum Institute of India Pvt Ltd and is involved in end to end pharmacovigilance activities of all vaccines and biologicals as well as clinical development. He has many national and international publications to add to his credit.

Naveen  Chhabra

Naveen Chhabra

Global Medical Safety Lead, Global Drug Development , Novartis, India

Dr Naveen is a gold medalist physician with experienced (more than a decade) in medical safety, clinical trials, and risk management. Currently, Naveen is working as medical safety lead, in Global drug department, Novartis. Prior to joining Novartis, Naveen has worked with various CROs/BPOs in various roles including global safety physician and project manager.

Varun   Dua

Varun Dua

Vice President -Professional Services, RxLogix, India

Varun has over 18 years of consulting experience in delivering large scale transformations for major pharmaceutical and biotech companies in Pharmacovigilance space. He is currently working as Vice President at RxLogix to focus on delivering end to end platform for adverse event management, reporting and surveillance. Passionate about patient safety, he leverages his experience of working with over 40 clients for driving technology initiatives focusing on safety platform modernization and automation of key processes using next gen technologies to improve quality, audit readiness and overall patient safety.

Dhanaraj  E

Dhanaraj E

Pharmacovigilance Lead- CDMA-BBL, Biocon, India

Dr. Dhanaraj E is serving in the capacity of Global Pharmacovigilance lead in BIOCON BIOLOGICS and has intimate knowledge and enriched 20 years of experience in clinical drug safety of pre-marketing innovative novel molecules, post-marketing biologics, biosimilars, medical devices and generic medicinal products drug safety, having served in leadership roles tasked with building Global Pharmacovigilance. He has deeply involved in drug safety from drug development program to post-marketing and have extensive experience in therapeutic areas of diabetes and immuno-oncology.

Sadhna Jitendra Joglekar, MD

Sadhna Jitendra Joglekar, MD

Senior Vice President Global Medical Affairs , Novartis, India

Decisive, results-oriented, transformational and passionate medical affairs and clinical research professional, Dr Sadhna Joglekar is the Head of Global Drug Development (GDD) Centre in India for Novartis. She is also a member of the NGSC (Novartis Global Service Center) Board in India. As Head of GDD in India, Sadhna leads the creation and implementation of the overall long-term vision and strategic priorities for GDD India that will enable growth for all GDD functions in India. She also plays a key role in facilitating cultural changes that empower GDD India associates to realize their full potential and have a big impact on patients.

Esther  Ninan

Esther Ninan

Director, Clinical Data Management, Novartis, India

Esther is an Inspiring and Passionate Corporate Leader. With total experience spanning two and half decades, she has managed diverse functions like Clinical Data Management, Statistical Programming, Medical Writing, Clinical Operations Support, Business Development and Customer Relationship Management. She joined Novartis 5 years back as Director, Data Management in Data Operations. She is currently ad interim Head of Clinical Data Acquisition and Management. Academically, she is a Microbiology Postgraduate and has completed her Executive Program in Business Administration from IIM Calcutta and Post Graduate Program for Leaders in Artificial Intelligence (PGP-AIFL).

John  Praveen

John Praveen

Associate Vice President – PV Account Delivery and PV Shared Services Offering , Lead, Accenture, India

John Praveen is the Associate Vice President – PV Account Delivery and PV Shared Services Offering Lead at Accenture. He has more than 14 years of experience working with 10+ clients across geographics in PV Project Management and Service Delivery (across Pharmacovigilance, Medical Devices Vigilance, Cosmetovigilance and Nutraceutical Vigilance). He also leads and manages the Business Process Transformation (including technology enabled i.e macros, RPA, AI and Analytics), E2E Project Transitions, Training and Capability Development and supports with PV Business Development including pre-sales and end to end bid management.

Shubha  Rao, DDS, MSc

Shubha Rao, DDS, MSc

Senior Director, Pharmacovigilance and Drug Safety, Indegene Pvt Ltd, India

Dr. Shubha has over 20+ years of experience and 12+ years in medical writing and Pharmacovigilance/drug safety. She has been associated with Indegene for 12 years and currently heads the Global Safety Operations. She is responsible for overall operations delivery and implement policies and processes to meet client expectations. She has worked with various Top global pharmaceutical companies on projects related to Pharmacovigilance, Aggregate Reports and Medical Writing. She has extensive experience in authoring and reviewing of various clinical, regulatory submission documents and safety reports across multiple therapeutic area.

Srikanth  S, MPharm

Srikanth S, MPharm

Associate Director, Head - SARA Literature center, Life Cycle Safety, IQVIA, India

Srikanth heads a global team of 120+ literature surveillance scientists located in India, China, & US, oversees vendors from Europe & Asia. In his role as head of a work function, he supports various aspects of the business unit, including strategy, pre-sales, business development, client relationship management, and operations. He works with Fortune 500 client base across Americas, UK, Europe, Japan, China, India, and Singapore to provide them with innovative technology solutions and business models to transform Pharmacovigilance (PV) processes. In his 11 years of Pharmacovigilance experience, he supported various PV domains like case processing, QA, training, literature review, aggregate reporting & signal detection.

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).

Viqar Ahmed Shah

Viqar Ahmed Shah

Senior Manager - Regulatory Affairs , Mylab Discovery Solutions Pvt. Ltd., India

Viqar is a MedTech professional and a nanotechnology enthusiast with 11+ years of experience in the medical devices industry. His experience includes working in India and Middle East. He is an ISO 13485:2016 certified Lead Auditor. He has a demonstrated history of working and leading teams in the areas of Research and Development, Regulatory Affairs & Quality Management System of medical devices. He has extensive experience on advanced products like absorbable stents (polymer and magnesium), drug coated balloon catheters, animal origin haemostats, wound care products, IVD reagents and analysers.

Jamal Anwar Baig, PhD

Jamal Anwar Baig, PhD

Multi Country Safety Head – South Asia & Indo-China (Vietnam), Sanofi, India

Jamal has 15 years of work experience in various capacities.Head of Pharmacovigilance country operations in India, Sri Lanka, Nepal, Bhutan Bangladesh, Maldives , Vietnam, Cambodia & Laos at Sanofi India – From Nov 2022. Previous positions held are PV Country Head at MSD Pharmaceuticals Pvt for 11 years. Team Leader, Pfizer Drug and Safety PV Process with Wipro Ltd. Lecturer NIPER, Govt of India. Industry Positions: Chairman of PV Council ISCR (India Society For Clinical Research) – Oct 2021- to till date. PV Task force OPPI. India PV update lead - EFPI. Leading role in development of PV guidelines for MAH in India released by CDSCO-NCC-PvPI in Sep 2017.Invited faculty at NCC-PvPI both for AMCs and PV Program.

Pankajkumar  Chhatrala

Pankajkumar Chhatrala

Founder, CEO, Orthoheal, India

Dr Pankaj is an innovator, inventor, researcher and entrepreneur. He is the co-founder of OrthoHeal and also the inventor of the revolutionary FlexiOH® technology that allows washable and ventilated orthopedic immobilization for post-fracture healing. His curiosity, passion, and enthusiasm for medical innovations that can improve lives at large scale outrank any other accreditation to his persona. Dr Pankaj is a medical professional with Bachelors in Medicine (MBBS) and a Masters in Medical Science & Technology (MMST) from IIT-Kharagpur. His entrepreneurial venture OrthoHeal based in Gujarat (India) & Dallas (USA) is constantly engaged in newer innovations and research to help human lives get better, free from pain and profoundly healthy.

Srikanth  Jata

Srikanth Jata

Director Head of Medical Safety Activities - Pharmacovigilance, Pharmalex, India

Dr. Srikanth Jata is currently working as the Director and Head of Medical Safety Activities -Pharmacovigilance in PharmaLex, India. In his current role he oversees and manages the Signal Management activities for over 30 clients. He also provides strategic advice to clients on managing Benefit-risk assessment for their products. He is a safety physician with an overall 15+ years of experience and over 12 years in Pharmacovigilance. He spent most of these years in Signal Management for products in post-marketing setting and in developmental phase. Prior to PharmaLex, he has worked with organizations like Cognizant, TCS, & Accenture.

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.

Ram  Mudaliar

Ram Mudaliar

Senior Director (India CDI Lead) Clinical Data & Insights (CDI) , AstraZeneca, India

Ram Mudaliar is currently working as Senior Director (India CDI Lead), Clinical Data & Insights (CDI) at AstraZeneca in India. In this role, he is accountable for establishing and expanding the CDI footprint in India, liaising with CDI Global Leaders & local leaders to develop and implement strategic decisions for the India site.

Bindu  Narang

Bindu Narang

Executive Director - Patient Safety Solutions, Labcorp, India

Bindu Narang heads the Aggregate Safety, Signalling and Risk Management Practice at Labcorp Drug Development. A pharmacist by qualification (post grad degree in Medicinal Chemistry) with 19 years supporting biopharma regulatory medical writing and 10 years in medical affairs/ marketing roles, Bindu has significant leadership experience, set-up regulatory, medical communications and regulatory operations; managed teams in Labelling, Medical Information, Aggregate Safety, Signal and Risk Management. Among key accomplishments, there’s setting up of a global medical writing team for Pfizer Global R&D’s Development Operations in 2004, and growing a Safety and Medical Writing practise for Sciformix in 2012.

Indira  Vadde

Indira Vadde

Consumer Safety Scientist, Haleon, India

Indira Vadde is a postgraduate clinical research professional with a total work experience of 13 years (including Pharmacovigilance, Clinical trials and Medical coding). She completed her Masters in ‘Drug Discovery and Development’ in UK and worked with various global pharmaceutical companies (in UK and India). She is associated with Haleon since 2016, worked in various therapeutic areas (such as Skin health, Oral health, Pain-relief, Respiratory). In Haleon, Indira is currently part of consumer safety writing team, and ensures authoring and development of benefit-risk assessments, safety risk management plans, safety signal evaluations, regulatory submissions and aggregate reports (medical writing).

Tarunjot  Singh, DDS

Tarunjot Singh, DDS

Director - Safety and Pharmacovigilance, Syneos Health, India

Dr. Tarunjot is currently working as Director, Safety and Pharmacovigilance with Syneos Health. He has more 12 years of combined clinical and pharmacovigilance experience. He has worked with multiple Contract Research Organizations including Quantum Solutions India, Parexel and Syneos Health supporting many large pharmaceutical clients. He has wide range of experience including project management, medical writing, case management and signal and risk management. He is Bachelor of Dental Surgery with lean six sigma black belt certification.

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