7th Annual Pharma Regulatory Summit 2024
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WHY SHOULD YOU ATTEND?
Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference.
Speakers
MAYUR PARMAR
FDA
PRATIK SHAH
BSV
PRATIK SHAH
BSV
PRATIK SHAH, VP Medical Affairs, Bharat Serums and Vaccines
• "Dr. Shah is an accomplished physician having worked in multiple areas related to patient care. After completing his MD in Pharmacology from Nair Hospital, he joined Sanofi in clinical development.
• Dr. Shah has also completed his Masters in Integrated Drug Development from Hibernia College, Ireland.
• For a decade, he handled a team of professionals working in medical affairs, regulatory affairs, quality assurance, and pharmacovigilance.
• Dr. Shah founded a CRO and consultancy business since January 2018.
• As a Consultant, he supports companies in developing medical affairs strategies, clinical trial protocols and real-world studies. He also writes on various topics related to real-world data at www.drpratikshah.com. He supervises the generation of real-world data in an Oncology Clinic with an immuno-therapeutic agent."
RASHMI HEGDE
GSK
RASHMI HEGDE
GSK
RASHMI HEGDE, Executive Vice President – Medical, GSK
• Dr Rashmi Hegde is currently Executive Vice President Medical Affairs GSK. Dr Hegde is a Paediatrician by training and has vast experience with the International Pharmaceutical companies.
• She has been associated for over 2 decades with several global Pharmaceutical companies such as Abbott, Solvay, Wockhardt, Piramal, Novartis. Dr Hegde has led Medical Affairs, Medico-Marketing, Medical Strategy, Clinical Operations, Regulatory, Pharmacovigilance and Medical Scientific Liaison for both Pharmaceutical and Biotechnology companies.
• Dr Hegde takes a keen interest in Pharmaceutical laws, and Safety Regulations (EU, US FDA & Asia Pacific), and Health Technology, Precision Medicine, Big Data and Real World Evidence/ Data from the TechnoCommercial and Regulatory compliance perspective and its applications to Clinical Studies and New Product Development. Dr Hegde has been a prolific speaker and writer at several international scientific forums and has published several scientific papers.
GEETA S
Ipca Laboratories
GEETA S
Ipca Laboratories
GEETA SHANBHAG, VP - Pharmacovigilance & Medico-Regulatory Affairs, Ipca Laboratories
• 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 14 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 hands on experience on both Aris G and Argus database, data migration, case processing, medical writing in pharmacovigilance, audits and inspection. In fact, Ipca successfully cleared its first US FDA pharmacovigilance inspection in 2017.
RAHUL GUPTA
USV
RAHUL GUPTA
USV
RAHUL GUPTA, Vice President, Regulatory Affairs, USV
• Rahul Gupta is presently Senior Vice President – Regulatory Affairs at USV Pvt Ltd. Prior to USV, he has worked in Sun Pharma, Piramal enterprise and many other pharmaceutical companies.
• Rahul has over 25 years of experience in the various pharmaceutical area. He has regulatory experience for development of new molecules from discovery to Phase I to Phase III.
• He has worked on cancer, anti-analgesic, anti-infective, metabolic disorder drugs in area of new drug development- having experience of successfully filing about 60 Phase I / II and III IND / CT applications across various continent, which includes USA, Europe, Australia, Canada and India.
• He has also worked on more than 70 ANDA’s and generic European submission for various dosage form- solid orals, parenterals, nasal sprays and complex generics etc, also having experience of DMFs/CEPs/ASMFs in regulated countries.
• He is M.Sc in Pharmaceutical chemistry and MBA in Operational management. He was also an adjunct faculty at Mumbai University (Bombay college of pharmacy), NMIMS and many other academic institutes in India.
BIJENDER M
Alkem Laboratories
BIJENDER M
Alkem Laboratories
BIJENDER MISHRA, Chief Information Security Officer (CISO), Alkem Laboratories
YASHMIN S
Sanofi
YASHMIN S
Sanofi
YASHMIN SHENOY, Senior Director - Regulatory Affairs, Sanofi
Accomplished professional with more than 2 decades of experience in pharmaceutical industry, mainly in Regulatory Affairs. Good communication skills with proven ability to build and lead efficient teams. Key responsibilities include determining regulatory strategy and leading life cycle management projects for business growth. Responsible for South Asia zone.
OMPRAKASH S
FDA (Maharashtra State)
OMPRAKASH S
FDA (Maharashtra State)
OMPRAKASH S. SADHWANI, Former Joint Commissioner & Controlling Authority, FDA (Maharashtra State)
Graduate in Pharmacy, Bombay University
Ex-Secretary, All India Drugs Control Officers' Confederation
Joined as Drugs Inspector, FDA in 1989 and was nominated by MPSC as Assistant Commissioner in 1999. Promoted as Joint Commissioner in March 2010.
Worked as Drugs Inspector, Thane, Intelligence Branch and Raigad.
Assistant Commissioner, FDA, Amravati, Intelligence Branch – Mumbai, Thane, a Joint Commissioner (Law) at Head Office and Joint Commissioner (HQ) & Drugs Controller, Maharashtra State.
Before joining FDA, worked in marketing for 3 years in Organon India Ltd., Calcutta and Lecturer in pharmacy for 4 years at Geetadevi Khandelwal Institute of Pharmacy, Akola.
Expert in Detection and investigation of various cases related to spurious drugs and other violations of Drugs and Cosmetics Act.
• Expert faculty on the subject of investigation and spurious drugs,
• Course coordinator for training program “Improving Investigation Skills of Drugs Control Officers”.
• Awarded by Government of Maharashtra as Best Officer Food & Drug Administration for the year 2008.
• Awarded Best Drug Control Officer at IPC Manipal by AIDCOC in year 2011.
• Presently working as Joint Commissioner HQ) & Drugs Controlling Authority, Maharashtra State.
• Member of Drugs Technical Advisory Board (DTAB) constituted under Drugs & Cosmetics Act 1940.
SAILESH YHNB
Novo Nordisk
SAILESH YHNB
Novo Nordisk
SAILESH YHNB, Associate Director, RA Device Established Products, Novo Nordisk
“Sailesh is Associate Director, RA Device Established Products Novo Nordisk Service Centre India, leading a team of Global Regulatory Device Leads and Professionals responsible for Life Cycle Management and MDR compliance of Medical Devices and Drug-Device Combination products. He has worked in the Regulatory Affairs CMC for Oral Solids, Sterile injectable, Biologics, Medical Devices and Regulatory Management, driving the strategy for MDR compliance and Global Device registrations.
Sailesh has a Master’s degree in Pharmaceutical Technology from Andhra University, PG Diploma in Business Management from NMIMS Distance School and has been coaching and mentoring aspiring regulatory professionals in CMC and Devices. He is passionate about science and leadership.”
KEDAR NAYAK
GSK
KEDAR NAYAK
GSK
KEDAR NAYAK, Head - Clinical Development, GSK
• Head of Clinical Matrix team comprising of subject matter experts and accountable for end to end study delivery of local interventional studies (phase IV, BA/BE studies) across Emerging markets.
• Over 16 years of experience in clinical research ( Phase II-IV, BA/BE) operations, and people management.
• Recognized with President’s award by Indian Society for Clinical Research for contribution as the Chair for the ISCR West Chapter in 2018 & 2019.
• Area of expertise - ICH GCP, Clinical Trials Management, Project Management, Clinical Development, Clinical Quality, BA/BE studies, People management. MBA
DEVEN BABRE
GSK
DEVEN BABRE
GSK
DEVEN BABRE, Former Director Analytics & Benchmarking, GSK
Leadership in areas of clinical research, primary in Biometrics and Pharmacovigilance. I am a post graduate in Life Science. Twenty-four plus years of experience in Biometrics, Pharmacovigilance and Pharmaceutical Industry. Have supported product development of tools across life science. Active in Automation & Technology + Clinical Trials System Landscape changes. Rich experience in consulting, project management, managing delivery and training. Proficiency in technologies, information dissemination and numerous databases in Biometrics and Safety data management Systems such as Oracle Clinical (Certified from CSS), Inform (Certified from Phase Forward), Medidata Rave, ARGUS, WebSys, SAS and Client Developed Systems. Strong communication skills when working with project managers, subject matter experts and customers. Skilled instructor and project leader. Currently working as Director, Life Science Digital Operation @ Cognizant.
Prior to this Cognizant I was working as Associate Vice President at TCS. Prior to TCS I worked as Director, Pharmacovigilance Operations @ Sciformix. Where I was managing PV operation involved in oversight of Delivery Managers, across Manila and India. Prior to that I worked with PharmaNet managing CDM as a Director. I served as board of directors for PharmaNet as a representation for India unit. Prior to PharmaNet I worked with Quintiles in capacity of Assistant Training Manager / Clinical Data Coordinator. Prior to Quintiles I worked in Wockhardt as Executive for Medical Information. I had started my career with TISS as Research Investigator. Has travelled to several destinations on globe for training or representing organization for Investigator or Management or Business Development meeting and attending conferences.
KRUPA BAHEKAR
Otsuka Pharmaceutical
KRUPA BAHEKAR
Otsuka Pharmaceutical
KRUPA BAHEKAR, Division Head - Regulatory Affairs, Otsuka Pharmaceutical
I am having more than 17 years’ experience in International Regulatory Affairs and holds a Master of Pharmacy in Pharmaceutical Chemistry and pursuing PhD in Regulatory Affairs.
I am currently Heading the Regulatory Affairs function in Otsuka Pharmaceutical India Private Limited and have led many successful global Regulatory Authority engagements, 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. I have led a team responsible for building and executing publishing, RIM, and compliance activities to support the regulatory organization.
I have experience in all aspects of regulatory operations including global submissions management and publishing, data and document management systems, regulatory information management and system support. I am also part of Organisation of Pharmaceutical Producers of India (OPPI) and have participated in putting patients at the core of all decision making and collaborating with all stake holders to find sustainable solution.
HARSHAD K
Merck Group
HARSHAD K
Merck Group
HARSHAD KOTHAWADE, Former Director, Head of Regulatory Management & Trade Compliance India, South East Asia, ANZ, Merck Group
• Associated with Pharmaceutical & Life Science Industry Since 2006, started as formulation development scientist & since 2007 hard core Regulatory affairs' activities.
• Well versed with general procedures as a part of Global Regulatory Affairs, general compliance & conduct of Multinational companies with Global Regulatory Authorities
• I am a proactive and achievement-oriented professional offering over 16 years of rich experience in Regulatory Compliance, Trade Compliance, and Imports & Export Operations, responding to queries, dossier, documentation, enhancing operational efficiency while reducing the cycle time.
• Currently associated with Merck Group as Director/ Head of Regulatory Management & Trade Compliance, Global Regulatory Affairs and Integrating the regional knowledge throughout the product lifecycle with aspects of effective management and strategy development.
• I am a forward thinking person with proficiency in implementing Government Affairs strategies, playing a pivotal role as the representative like IPEC, FICCI, ISPE India Affiliate, PDA India, Chemexcil, RX 360 etc., Regulations and guidance governing drugs during development and validations including post-marketing, in the US/EU, ROW & Emerging Markets, E CTD, Minitab 14, Statistica, IBM SCORE, Take Solution, RIMS VEEVA Vault, Educe, Educe SPL, InDesign Software for Actual Labeling Preparation, SAP – Global Trade Service (GTS) and paper CTD submissions including Dossier Management by Educe Solutions, IBM SCORE, ECTD Express by ISI Regulatory Solutions.
VAIBHAV SALVI
Sanofi
VAIBHAV SALVI
Sanofi
VAIBHAV SALVI, Director & Head – Clinical Study Unit, India and South East Asia, Sanofi
• Dr. Vaibhav Salvi is a physician by training with specialization in Electro-cardiology.
• He has more than fifteen years’ experience in clinical research and drug safety.
• His research work has been presented at national conferences (Cardiological society of India, Indian Society of Medical Statistics, The Chennai Paediatric Electrophysiology Symposium) and international conferences (Drug Information Association, Statisticians in Pharmaceutical Industry, International Congress on Electrocardiology).
• He has more than a dozen publications to his credit published in journals like British Journal of Pharmacology, Journal of Pharmacology, Journal of Electrocardiology and Diabetes Care to name a few.
DILIP PAWAR
Unichem Laboratories
DILIP PAWAR
Unichem Laboratories
DILIP PAWAR, Global Head - Medical Affairs and Pharmacovigilance, Unichem Laboratories
Heading Medical Affairs, PV and Global Clinical Development. I am oncologist and also Covid Expert
POOJA THAKUR
Advanz Pharma
POOJA THAKUR
Advanz Pharma
POOJA THAKUR, Associate Director, Regulatory Intelligence & Reporting, Advanz Pharma
MARTINA GOMES
Bayer
MARTINA GOMES
Bayer
MARTINA GOMES, Head, Reg Affairs – CH, Bayer
Martina Gomes is the Regulatory Head for Bayer’s Consumer Health Division in India. She has over 16 years of Pharma and Consumer Health industry experience working in organizations like Pfizer & Sanofi across diverse portfolio of Biologicals, Specialty, Animal Health, OTC, Nutritionals and Ayush for South Asian countries. In her various roles, she has had opportunities to work closely on Health Authority interactions, Registration strategies, Internationa lproduct launches, Product life cycle expansions, business growth strategies and various other organizational projects. Martina has been involved with various Trade associations for the last 10 years and has worked on many initiatives to shape the external regulatory environment.
Martina strongly believes in building a regulatory framework and sustainable healthcare solutions to enable our Indian consumers to be in charge of their health and foster Self-care in our country.
Martina post-graduated from Sophia College, Mumbai with a Mastersin Microbiology and further a degree in Clinical Research from the Bombay College of Pharmacy, Kalina. She’s an active member on the Board of Studies of Sophia College since 2021. She joined Bayer India in July 2020. In her earlier stint, she was the Head of Regulatory Affairs CH for South Asia at Sanofi.
SADANAND K
Fresenius Kabi
SADANAND K
Fresenius Kabi
SADANAND KULKARNI, Head - Medical, Regulatory, Vigilance & Quality South Asia, Fresenius Kabi
Current Position
- Head, Medical, Regulatory, Vigilance, Quality, Fresenius Kabi India Pvt. Ltd., since Jan 2019
Professional experience:
- Vice President, Medical Affairs and Clinical Research, Fresenius Kabi India Pvt. Ltd., Pune/Gurgaon: July 2011 to 2018 (with Fresenius Kabi, since 2003)
- Assistant Medical Director, Serum Institute of India, Pune., Sept 2000-May 2003
- Teaching profession: February 1996 - August 2000
- M.D. (Clinical Microbiology): 1995: BJ Medical College, Pune
- DIB (Diploma in International Business) 2003: Symbiosis Institute of International Business
- Trained in clinical nutrition and volume therapy, Fresenius Kabi Advanced Nutrition course and Fresenius Kabi Advanced course in transfusion alternatives
Clinical/research interests:
- Co author of papers presented in ESPEN 2004, 2005, PENSA 2003, NATA, 2006 in the field of Clinical Nutrition and Volume Therapy
- 4 publications in the field of Clinical Microbiology and Vaccinology
Special areas of interest:
- Clinical Nutrition and immunonutrition
- Hospital acquired infections
- Clinical trials under GCP
MAYUR M
Alkem Laboratories
MAYUR M
Alkem Laboratories
MAYUR MAYBHATE, Head Medical Affairs, Alkem Laboratories
• Pharmaceutical physician, with >10 years of experience and expertise in key levers of medico-marketing
• Worked across medical and regional medical affairs, handled key super-specialty therapy areas and big brand’s in the industry viz. Cremaffin, Duphalac, Dupahston, Vertin, Influvac to name a few
• Spearheaded key project in medico-marketing, KOL profiling, Young doctor program in India
• Integral part of clinical research team across Abbott/Alkem and supported Phase III/Phase IV and RWE studies
• Aspired to lead passionate, scientifically sound, ethical and innovative medical team to impact patient’s lives at large
Professional Journey :
• MBBS: Dr. VM Govt Medical College Solapur (2002-2008)
• MD Pharmacology: Indira Gandhi Govt Medical College Nagpur (2009-2012)
• Lecturer Pharmacology: Govt Medical College Nagpur (2012-2013)
• Medical Advisor: Jubilant Life Sciences (2013-2014)
• Medical Advisor: Abbott India Ltd (2014-2016)
• Sr Medical Advisor: Abbott India Ltd. (2016-2019)
• Sr. Manager: Abbott India Ltd (2019-2022)
• Head Medical Affairs: Alkem Labs Ltd (2022 – Till date)
GIRISH SANE
Macleods Pharmaceuticals
JEGAN ISRAEL
Zydus Group
JEGAN ISRAEL
Zydus Group
JEGAN ISRAEL, Head of Quality & Compliance (General Manager), Zydus Group
I am a quality professional having 18-plus years of experience with a proven track record of excellence. I aim to set the strategies for overall quality operations, and cultural transformations to achieve compliance with sustained growth and profitability. I have vast experience working with regulatory bodies. I possess sound knowledge of the entire value chain from drug manufacturing to distribution including active pharmaceutical ingredients. I have an uncompromising commitment to quality and excellence.
I have always been purpose-driven and feel humbled to know that we serve patients daily. I am driven to ensure the culture that I work in is one of accountability and responsibility. I always believe that in the pharmaceutical environment, each day one has to bring their A-game to the workplace and this is done by communicating the purpose, the reasons why we do, what we do, empathy for the staff, and strict adherence to procedures beneficial for the end-user of our work who is a patient.
SWEETY MATHEW
Novo Nordisk
SWEETY MATHEW
Novo Nordisk
SWEETY MATHEW, Regulatory Professional, RA CMC Biotech & Rare Disease, Novo Nordisk
• Sweety Mathew is part of Global Regulatory Affairs- CMC Rare Diseases team in Novo Nordisk and was earlier associated with Biocon Biologics handling peptides and biosimilars.
• Prior to being a Regulatory professional, she was associated with BioMarin Pharma- UK (Rare Diseases) and part of RnD team as a Cell and Molecular Biologist.
• She is a post graduate in Bioinformatics and Applied Biotechnology from University of Westminster, London.
• She believes in nurturing an inquisitive and an explorative culture to be part of this exciting race to create a more scientifically advanced tomorrow.
GODHULI C
Sanofi
GODHULI C
Sanofi
GODHULI CHATTERJEE, Senior Medical Advisor, India-South East Asia, Sanofi
• As a Senior Medical Advisor at Sanofi, I leverage my 18 years of experience and my MD in Pediatrics to provide medical leadership and strategic direction for the India-South East Asia Cluster.
• My mission is to improve patient outcomes and access to innovative therapies in the areas of diabetes, rare diseases, and immunology, which are my fields of expertise and passion.
• I have worked in the area of SWITCH for global consumer healthcare products.
• Another area of exposure and contribution has been in the discipline of gene therapy for rare blood disorders and rare diseases.
• In my digital journey, I have worked in e-consent, decentralized clinical trials, patient technology and design thinking.
• I have also participated in cross-industry collaborations and publications, such as the novel measurement of sleep in rheumatoid arthritis, which was featured in the Digital Biomarkers journal, as a TransCelerate Biopharma Inc. workstream co-authored article.
• Furthermore, I have contributed to clinical research safety and have ensured the highest standards of pharmacovigilance for clinical trials and post-marketing surveillance.
• During my tenure as the Asia Pacific regional point of contact for fellow safety leads in clinical research, I have worked across varied geographies and work culture, creating a sense of camaraderie and bonhomie among colleagues, embracing diversity and inclusion in daily work.
• Additionally, I deliver high-quality medical education and training to internal and external stakeholders, using the latest digital platforms and tools.
• I am comfortable with a matrix structure and can accommodate time zone differences in my regular work.
SAKHARAM G
RENOVARE Healthcare
SAKHARAM G
RENOVARE Healthcare
SAKHARAM GARALE, Founder & CEO, RENOVARE Healthcare Solutions
• Dr. Sakharam Garale, is Physician with E-MBA from IIM-Indore, BCMAS(USA), perusing a PhD in management with over 20 years of rich experience; in Global Medical Affairs, Medico-marketing, Clinical Research & Development, Public Health, Regulatory Affairs, Pharmacovigilance, Project Management, Vendor Management, Compliance, People Management in the Pharmaceutical & Healthcare industry.
• He has had exposure to domestics and international markets with MNCs like Mylan Laboratories Ltd, Abbott Ltd, Quintiles Translational Ltd, Sandoz India Ltd and Glenmark Pharmaceuticals Limited.
• He brings extensive experience of working in international markets i.e. Emerging Markets (LATAM, ASIA, Africa and JANZ) along with India for Global Medical Affairs, Medico-Marketing, Public Health, Commercial leadership, Operations and Strategy.
• He also has upper hand in setting up the units and managing Bioavailability & Bioequivalence studies with leading CROs, local and MNC Pharma organization in the industry at different levels.
• He is a well known KOL, Speaker and Trainer in Healthcare industry seen at various events and conferences in India and APAC.
• Associated with small and medium size healthcare/pharmaceutical startups as consultant for operations and strategy. With his vast international experience and exposure, he brings a detailed insights from international healthcare markets for commercial exchange.
• Founded Renovare Healthcare Solutions in 2018 with its office in Navi Mumbai to cater to KOLs, Hospitals and Pharmaceutical Industry serving global clientele.
• As part of CSR, Renovare has trained 7000+ people from different sections of society on covid-19 awareness during 1st wave and treated 5000+ covid-19 patients with a home care model during both covid-19 waves.
MANGALA KOTNIS
Abbott
MANGALA KOTNIS
Abbott
MANGALA KOTNIS, Former Head Regional Medical Affairs , Abbott
• Is a health Care consultant with more than 19 years in pharmaceutical industry with cross functional medical leadership Skills, a proactive hands-on approach to medical direction, ability to work productively with diverse set of internal and external stakeholders.
• She has strong expertise in driving medical advocacy; generation of clinical / real - world evidence and has experience across domestic and international markets has business acumen with local (India) Regional (AMAC) experience.
• Has lead and managed the Centre of Excellence for Managed Access Programs (MAP COE) within the Global Medical Governance Team; with experience of Setting medical standards and developing internal policies and guidelines according to applicable laws and regulations; to drive global, regional and local implementation of standards for assigned medical programs.
• She has led cross-functional projects to implement and continuously improve medical standards, processes and systems for Novartis.
• She has managed all aspects of event execution worked along brand teams from identifying and engaging the right opinion leaders to designing the agenda and optimizing the participant experience and worked on driving advisory boards, symposia, expert forums, global investigator meetings, educational webinars. Present Faculty at Mitcon Consultancy Services for Clinical Research and Medical writing.
• She has driven continuous function development and implementation of innovative business models, process while focusing on high impact and value for HCPs and their patients;
• She has Partnered with digital companies to provide new technologies to support field interaction; present advisor to IT company who is creating A1 tool for cancer patients.
• Provided strategic direction for KPIs, metrics, resource deployment and analytics to demonstrate impact and value of external scientific engagement.
• She has to her credit 8 international publications and 1 patent and has been active in medical writing, creation of conference posters, literature searches and supporting evidences and preparation of plain language summaries.
• She has also created content for blogs, social media post and website.
• She is pharmaceutical physician with medical degree and Phd in Pharm Science with MBA in Entrepreneurship, Pursuing AIML In healthcare course from Sandford Medical School; she is based in Mumbai.
KUSHAL SARDA
Shalina Healthcare
KUSHAL SARDA
Shalina Healthcare
KUSHAL SARDA, GM & Head, Medical Affairs, Clinical Research & PV, Shalina Healthcare
Currently I am working as GM & Head–Medical Affairs, Clinical Research & PV in Shalina Healthcare, an African MNC. Prior to Shalina Healthcare, I was associated with Abbott India Ltd. & Ranbaxy Labs. I have more than 10 years on experience in medical affairs in multiple therapies like Neurology, Psychiatry, Metabolics, Consumer, Infections & Gastroenterology. This also includes 2 years support to International Business in countries like Sri Lanka, Maldives, Nepal & Bhutan which had multiple therapies and brands. I have got 13 awards for my contribution towards the core value of company.
On clinical studies front, I have initiated & executed more than 25 clinical studies of all phases, with more than 15 publications, 8 presentations & 5 therapy guidelines. I have experience of working in CRO for BA/BE studies along with 4 years of clinical practice. I have completed my MBBS from JNMC, Wardha and MD in Pharmacology from Bharati Vidyapeeth, Pune. My interest areas are Post marketing surveillance, Digital healthcare, Medico-marketing, and Finance. My hobbies are travelling, reading, food tours and formula1.
ANANT PATIL
Dr DY Patil Medical College
ANANT PATIL
Dr DY Patil Medical College
ANANT PATIL, Associate Professor, Department of Pharmacology, Dr DY Patil Medical College
PRASHANT B
CliniSearch
PRASHANT B
CliniSearch
PRASHANT BODHE, Director, CliniSearch
Profile Description:
Pharmacologist with 24+ years of experience in Regulatory Affairs; Quality Compliance and Systems; Global Clinical Research (Phase I-III) & Pharmacovigilance; API, Toxicology; Formulation Development; Bioavailability, Bioequivalence Studies, Pharmacokinetics
Professional Experience
Director
CliniSearch; Proprietor; Consultant, Pharmaceutical Research and Development
June 2014 - Present
Director of Operations, Medanta Duke Research Institute (MDRI)
Medanta The Medicity Sector 38, Gurgaon, Haryana, 122001, India; Aug 2013 – June 2014
Associate Director, Clinical Operations & Office Head, Sri Lanka Quintiles Research (India) Pvt. Ltd.; Feb 2011 – June 2012
Director, Clinical Development Center
Advance Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Center, Navi Mumbai; Jan 2008 - May 2010
Vice President
CliniSearch Biotechnologies, Navi Mumbai, India; Dec 2003 - Dec 2007
Deputy General Manager (Senior Clinical Pharmacologist) Lupin Research Park, Pune, India; Dec 2002 - Dec 2003
Head Regulatory Affairs (India Region) Cipla Ltd., Mumbai, India; Jul 2000 - Dec 2002
Assistant Manager, Department of Pharmacology, Toxicology, Research and Development
Cadila Pharmaceuticals Ltd., Ahmedabad, India; Since Dec. 1998 to Jul. 2000
Senior Research Fellow
Liposome Clinical Pharmacology Center, Dept. of Clinical Pharmacology, Seth G.S. Medical College and K.E.M. Hospital, Mumbai, India; Nov. 1991 - Dec. 1998
Research Fellow
Indian Institute of Toxicology, Pune, India; Apr. 1988 - Oct. 1991
Professional Memberships
- Life member of ACTREC Alumni Association, Tata Memorial Center, Kharghar, India
- Indian Pharmaceutical Association (Life Member)
- Registered Pharmacist (Life)
Publications
- 13 scientific papers in indexed International (4) and National publications (9)
- Presentations: http://www.slideshare.net/PrashantBodhe
“Recent regulatory developments to explore innovative strategies”
Conference Schedule
Meet to learn and network with your conference colleagues.
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
MARKET UPDATES
09:20 – ‘Role of RWE in generating insights for regulatory filings and commercialisation’
PRATIK SHAH, Vice President - Medical Affairs, Bharat Serums and Vaccines
PATIENTS SAFETY
09:50 – KEYNOTE PANEL DISCUSSION: Patient Safety Guidelines and Regulations
• “Engaging Patients for Patient Safety”, “Elevate the Voice of Patients”
• Patient Safety and Quality Improvement Rule (Patient Safety Rule)
• Adopting the technological side for enhancing patient safety in recognizing early warning symptoms using advanced devices
• Transparency in sharing patient’s experiences, needs and decisions
• Active involvement in establishing a new patient safety environment - Trust creation
• Comprehensive Guidelines for clinical and hospitals for the next normal
Moderator
DILIP PAWAR, Global Head - Medical Affairs and Pharmacovigilance, Unichem Laboratories
Panellists
AMIT PANDEY, Executive Vice President & General Counsel, GSK
RAHUL GUPTA, Vice President, Regulatory Affairs, USV
GEETA SHANBHAG, VP - Pharmacovigilance & Medico-Regulatory Affairs, Ipca Laboratories
MAYUR MAYBHATE, Head Medical Affairs, Alkem Laboratories
10:40 – Morning Coffee / Tea & Discussion
AUDITS & INSPECTIONS
11:10 – DISCUSSION WITH EXPERTS: Quality audits to ensure compliance with regulatory requirements
• Ensuing trends with unparalleled alterations in data auditing complexities
• Quality audits – critical observance and current developing scenario in documentation
• In what aspect does the extension in technological innovations and inventions work together in moderating the accurate coherence of reports
• Escalation of regulatory QMS and managing the audit gaps
• Audit alignment with GMP considerations and legal requirements
• FDA – warning letters, approvals, and advancements in regulatory inspections
• Decisiveness in the zestful reporting of the auditing data to the Government authorities by the auditors and their crucial role play
• Regulatory Intelligence critical for compliance
Moderator
SAKHARAM GARALE, Founder & CEO, RENOVARE Healthcare Solutions
Panellists
POOJA THAKUR, Associate Director, Regulatory Intelligence & Reporting, Advanz Pharma
MARTINA GOMES, Head, Reg Affairs – CH, Bayer
JEGAN ISRAEL, Head of Quality & Compliance (General Manager), Zydus Group
SANTOSH SACKET, Director-Quality Assurance and Innovation, Expecto Health Science
12:00 – Practical guidance for drug registration compliance in India
• Key requirement of Drug registration in India through online SUGAM portal
• Requirements for Post Approval changes in India
• Major challenges faced by Industry.
• Futuristic approach set by government to have common window through NSWS portal.
KRUPA BAHEKAR, Division Head - Regulatory Affairs, Otsuka Pharmaceutical
12:20 - Networking luncheon
MEDICAL DEVICES
13:20 – DISCUSSION WITH EXPERTS: Evolving Predicaments in Regulations of Medical Devices
• How organized can the approval of medical devices be? – Unfolding the complicated and time-intensive process which is simultaneously resource-consuming
• Getting on with the new regulations and governance under IMDR
• Trailblazing strategies in the manufacturing of domestic devices rather than depending on importing
• Regulatory streamlines and appealing expenditures considerations in the manufacturing of prospering medical devices
• In what ways we can build a relationship with the international and domestic markets in interchanging with medical devices? – Bearing in mind the differences between other nations’ regulations
Moderator
OMPRAKASH S. SADHWANI, Former Joint Commissioner & Controlling Authority, FDA (Maharashtra State)
Panellists
MAYUR PARMAR, Drugs Inspector (Deputy Collector, Gujarat Government), FDA
SAILESH YHNB, Associate Director, RA Device Established Products, Novo Nordisk
HARSHAD KOTHAWADE, Former Director, Head of Regulatory Management & Trade Compliance India, South East Asia, ANZ, Merck Group
GODHULI CHATTERJEE, Senior Medical Advisor, India - South East Asia, Sanofi
MANGALA KOTNIS, Former Head Regional Medical Affairs (MSL/ FME function), Abbott
14:10 – Changing Regulatory landscape - Importance of Critical Thinking in Regulatory Intelligence
• What is Regulatory Intelligence and its significance
• Why is Critical Thinking important in Regulatory Intelligence?
• Digitalisation in Regualtory Intelligence
• Case studies
POOJA THAKUR, Associate Director, Regulatory Intelligence & Reporting, Advanz Pharma
BIOSIMILARS
14:40 – “Regulatory considerations for Novel and Biosimilars”
• Introduction to Biosimilars and complex molecules and how different they are
• Overview of Regulatory framework for Biosimilar development
• Robust CMC package
SWEETY MATHEW, Regulatory Professional, RA CMC Biotech & Rare Disease, Novo Nordisk
15:10 – Afternoon Tea / Coffee
RWE / RWD
15:30 – DISCUSSION WITH EXPERTS: Real-world evidence - How it could be used to support regulatory decision-making
• Directing patient health and healthcare delivery data which are regularly acquired from several root sources
• Examining the current RWE regulatory systems to assess the potential for integrating patient experience into medical product decisions using RWE
• Whereas RWE still poses many new technological and policy problems, what real-world endpoints are appropriate?
• How would sponsors mitigate bias effectively to assess the therapy’s true effect?
• Assessing why RWE is becoming highly relevant to regulatory decision-making in the scope of developing evidence standards
• Studying the current RWE regulatory programs and the advantages of addressing various data sources that may serve RWD and lead to RWE evaluations of medical products
Moderator
ANANT PATIL, Associate Professor, Department of Pharmacology, Dr DY Patil Medical College
Panellists
RASHMI HEGDE, Executive Vice President – Medical, GSK
BIJENDER MISHRA, Chief Information Security Officer (CISO), Alkem Laboratories
DEVEN BABRE, Former Director Analytics & Benchmarking, GSK
GIRISH SANE, Section Head PV, Macleods Pharmaceuticals
KUSHAL SARDA, GM & Head, Medical Affairs, Clinical Research & PV, Shalina Healthcare
CLINICAL TRIALS
16:10 – DISCUSSION WITH EXPERTS: Clinical Trials - Regulatory Progress
• Enactment of New Drugs and Clinical Trial Rules 2023
• PV in clinical trials and probing
• Clinical Trials – From the standpoint of regulatory submissions
• Drug testing limitations and other implying ethical issues.
• Remote trials – approaching strategies concurring with reality
• Clinical investigation under regulatory circumstances
• Where are we heading and the way forward?
Moderator
PRASHANT BODHE, Director, CliniSearch
Panellists
VAIBHAV SALVI, Director & Head – Clinical Study Unit, India and South East Asia, Sanofi
KEDAR NAYAK, Head - Clinical Development, GSK
YASHMIN SHENOY, Senior Director - Regulatory Affairs, Sanofi
AKSHAYA S. ODAK, Head Regulatory Affairs (Biotech), Lupin
SADANAND KULKARNI, Head- Medical, Regulatory, Vigilance & Quality South Asia, Fresenius Kabi
17:00 – Closing remarks and end of conference
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