29th Pharmacovigilance India 2022
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.
Event Speakers
BANGARURAJAN
CDSCO (New Delhi)
SAKSHI S D
Johnson & Johnson
SAKSHI S D
Johnson & Johnson
SAKSHI SHRIVASTAVA DESAI, Associate Director International Pharmacovigilance Strategy Realization, Johnson & Johnson
MUKESH GORI
Novartis
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.
ANUJA JAWALE
Organon
ANUJA JAWALE
Organon
ANUJA JAWALE, Associate Director RA and PV Strategic Sourcing and Vendor Management, Organon
• A Homeopathic Physician by Qualification with a Post Graduate Diploma in Clinical Research.
• Total of 14 years of experience in Pharmacovigilance. Over the 14 years she has been associated with companies like Sanofi Aventis Pvt. Ltd, Tata Consultancy Services, Lupin Ltd. And Abbott India Ltd.
• Currently designated as Associate Director Regulatory Affairs/Pharmacovigilance Strategic Sourcing & Vendor Management team within Organon’s Research & Development team.
• Strategic Thinker and Problem-Solving Abilities leading to success of many projects and streamlining processed. Major experience and skill set lies in strategizing and coordinating with cross functional teams
• In-depth experience in end-to-end Pharmacovigilance operations Global function as well as Affiliate experience is managing Pharmacovigilance for region and countries.
• Regular faculty for training PvPI staff on various pharmacovigilance topics
RAJESH R
Pfizer
RAJESH R
Pfizer
RAJESH RAJENDRAN, Director - Projects and Vendor Management Lead, Worldwide Safety, Pfizer
A leader in Pharmacovigilance industry, with more than 15 years of experience in leading teams (ICSR – Case Processing, Aggregate Reporting and Regulatory submission). Currently working with Pfizer pharmaceuticals as Director – Projects and Vendor Management Lead with primary responsibility to oversee the Pharmacovigilance outsourced projects since 2016.
Gathered a wide knowledge of project management and acquired a good experience of people management, operations management and performance/audit management. A passionate mentor and coach and budding managers.
VIPIN SETHI
Cadila
VIPIN SETHI
Cadila
VIPIN SETHI, Global Head – Pharmacovigilance Head – Medical Affairs – ISBU, Cadila
UJWALA NAIK
Johnson & Johnson
GEETA S
Ipca Laboratories
GEETA S
Ipca Laboratories
GEETA SHANBHAG, Sr. General Manager – 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.
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
MILIND ANTANI
Nishith Desai Associates
MILIND ANTANI
Nishith Desai Associates
MILIND ANTANI, Leader, Pharma and Healthcare, Nishith Desai Associates
Dr. Milind Antani is a Partner in charge of the Pharma & Healthcare Practice a at the multi-skilled, research-based international law firm, Nishith Desai Associates with offices in Mumbai- Nariman Point, Silicon Valley, Bangalore, Singapore, New Delhi and Mumbai – BKC, Munich and New York. He is also partner in-charge of Social Sector practice and Nanotechnology practice.
Dr. Antani represents clients on strategy matters including corporate mergers and acquisitions, investments, regulatory and transactional matters, intellectual property prosecution and litigation, collaborations including joint ventures and formation of new companies. He also advises clients in e-Health and tele-medicine on business strategy from legal and regulatory perspective.
DEEPA ARORA
CLINEXEL Life Sciences
DEEPA ARORA
CLINEXEL Life Sciences
DEEPA ARORA, Chief Executive Officer, CLINEXEL Life Sciences
Deepa is an Experienced Clinical Development and Drug Safety physician. She served in leadership positions in pharma companies for almost two decades, leading global clinical research and pharmacovigilance activities. Currently she is the Chief Executive Officer of Clinexel Life Sciences Pvt Ltd.
CLINEXEL is an agile, customer focused full service, Clinical Research Organization, that provides clinical research, pharmacovigilance, regulatory, auditing and medical writing services to pharma, biotech and medical device companies. At CLINEXEL, our mission is to partner with early-stage pharma and biotech companies for fast and efficient clinical development of their innovations.
GOPAL NANDAN
Oncquest Laboratories
GOPAL NANDAN
Oncquest Laboratories
GOPAL NANDAN, Head - Clinical Trial & SR, Oncquest Laboratories
Gopal Nandan is Heading Clinical Trials & Patient Support Programs at Oncquest Laboratories Ltd. Into the industry from last 15 years out of that 10 years into central Laboratory adding value addition to the ongoing Clinical Research and Patient Support Programs for all Local & Global studies.
In past worked for the Global Leaders in Central Laboratory like Quest Diagnostics and Q2 Lab Solutions looking upon across the globe with his valuable experience and rare expertise in this particular field which is less talked and discussed. He has an ambition to make his organization Number “One” in India for Clinical Trial Central Laboratory.
VALLABH D
Glenmark
VALLABH D
Glenmark
VALLABH DESHPANDE, Head of Global PV Operations, Glenmark
•13+ years of experience in Pharmacovigilance with a varied portfolio of handling Pharmacovigilance Operations, Safety Consulting, Business Development with various BPO,KPO, CRO & Pharmaceutical companies.
•Expertise in setting up Pharmacovigilance System, Process optimization, System Validation & Project Management.
MANGALA K
Abbott
MANGALA K
Abbott
MANGALA KOTNIS, Former Head Regional Medical Affairs, Abbott
Medical Thought Leader with 18+ years of experience 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, strong expertise in clinical/real-world evidence generation, and science led business acumen across domestic and international markets with local (CPO India), Regional (AMAC) and Global experience.
Experience of driving strategic and tactical alignment between Global, Region & Country brand teams to ensure that all SI were in place for new launches in countries. Conceptualized new medical strategies for marketing promotion, and leading medical launch team, developing a strong medical engagement plan, incorporating diverse Medical functions and capabilities.
Spearheaded the Centre of Excellence for Managed Access Programs (MAP COE) within the Global Medical Governance Team.Established internal guidelines and medical standards as per the laws and regulations; accountable for driving global/regional/local implementation of standards for the assigned medical programs, ensuring they are aligned with medical functions.
Identified the quality and compliance risks and established sustainable mechanisms to mitigate them.Spearheaded cross-functional projects to execute and enhance medical standards and processes.Coordinated with the CMO (Chief Medical Office) leadership to set proper readiness plans for Health Authority inspections and internal/external audits.
POOJA THAKUR
Advanz Pharma
POOJA THAKUR
Advanz Pharma
POOJA THAKUR, Head Regulatory Intelligence & Reporting, Advanz Pharma
Pooja Thakur, MPharm, is the Regulatory Intelligence Head at Advanz Pharma. Pooja is an experienced Regulatory Professional with more than 16 years’ experience in pharmaceutical industry contributing towards Regulatory Affairs involving CMC submission, review and life cycle Management. She has worked in operational excellence and regulatory intelligence roles in her previous profiles.
She has contributed to Pharmaceutical Organisations in establishing Regulatory Intelligence process and Inhouse Regulatory intelligence database for the surveillance of regulatory landscape. She is an active member of Regulatory Professional groups like RAPS, DIA and TOPRA and also represents from India in the RI SPIN of TOPRA. Her past experience includes working with Cadila Pharma and Cipla and currently at Advanz pharma. She can be contacted at pooja.thakur@advanzpharma.com
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.
SIVA K B
Teva
SIVA K B
Teva
SIVA KUMAR BUDDHA, Global Phv Surveillance Physician Sr Manager, Teva
Dr Siva Kumar BUDDHA is a Physician by education and is a lean six sigma green belt. During his career in Pharmacovigilance he has worked for different Service Providers and Pharma Companies. At present he is working at the capacity of a Global Safety Survelliance Physician Sr Manager at Teva Pharma. He has worked on different Automation initiatives on Pharmacovigilance and have being a trainer for many PV associates. He has spoken on different PV topic in several conferences.
VISHWAS SOVANI
Pharmawisdom
VISHWAS SOVANI
Pharmawisdom
VISHWAS SOVANI, Founder Director, Pharmawisdom
• Founder Director, Pharmawisdom, a consultancy that focuses on clinical research, training and pharmacovigilance coaching.
Qualification:
• MD (Pharmacology), Mumbai University.
• Diploma in Management, IIM Ahmedabad.
• Over 35 yrs in pharma industry in medical department,
• Responsible for Clinical research, regulatory & medicomarketing and pharmacovigilance in companies like Sarabhai, Cipla, FDC, Cyanamid/Wyeth, Organon, in local and regional roles
• Was also Head of Pharma delivery in TCS BPO
• Retired as India Head for Revogenex Inc.
Additional professional activities:
• Chairman of the Ethics Committee of the Kaushalya Medical Trust Hospital.
• Medical expert in Ethics Committee for Jaslok Hospital.
• Ex-Chairman of Institutional Review Board of Bombay College of Pharmacy, Mumbai.
• Ex Referee and examiner for M. Pharm. (Pharmacology) & Ph. D (Pharmacology) course of University of Mumbai.
Publications:
BOOKS: Updates in Ophthalmology as editor.
JOURNALS: Over 45 publications in various therapeutic areas.
VRUNDA PANDYA
SPARC
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
SADANAND K
Fresenius Kabi
SADANAND K
Fresenius Kabi
SADANAND KULKARNI, Head - Medical, Regulatory, Vigilance, Quality, 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
KAVYA KADAM
KAVYA KADAM, Consultant Global Clinical Trials
Dr. Kavya Kadam is currently a Consultant for Global Clinical Trials with 18+ years of experience including CRO, Biopharmaceutical industries and Clinical Practice. She is a medical graduate from Seth G. S. Medical College, Mumbai and a MBA from SP Jain Global School of Management, Mumbai.
In her current profile, Dr. Kavya Kadam consults globally in areas of Clinical Operations, Trials and Project Management.
Dr. Kavya's niche area is in helping organisations and teams achieve operational excellence by promoting process improvements and excellence.
She also helps organisations build organgrams and goal setting to achieve organisation goals.
Dr. Kavya Kadam has managed Global Clinical Trials and Clinical Operations for International Clients. While doing so, she has had hands-on-experience of managing trials in various therapeutic areas including biosimilars, generics, monoclonal antibodies, stem cell, vaccine, proof-of-concept trials to name a few.
INDU NAMBIAR
Boehringer Ingelheim
INDU NAMBIAR
Boehringer Ingelheim
INDU NAMBIAR, Local Patient Safety Lead, Boehringer Ingelheim
• Indu Nambiar is a Home Science Graduate with Majors in Nutrition. She pursued her P. G Diploma in Dietetics, and is a registered Dietician and holds a MBA in Service Excellence from Welingar’s
• Started her career in the Pharmacovigilance field in 2006, when she joined Novartis India Ltd. as Executive – Drug safety & Epidemiology (DS&E) and has been associated with this field for the past 15 years and continues
• She is a life time member of Indian Society for Clinical Research (ISCR) and was instrumental in the formation of the PV working Group within ISCR in 2014. She was the Co-Chair for the PV council from its inception for 4 years (2015 – 2019)
• Is responsible for academic collaborations with major universities to co-ordinator, prepare the course, identify faculties and conduct such PV certification courses
• Has contributed by being on the Scientific and Organising committees for the PV symposiums conducted by PV Council ISCR and was honored by the Hall of Fame during the ISCR Annual conference held in Mar, 2021.
• She has been a resource person in several National and International Pharmacovigilance conferences including the PV symposiums conducted by PV Council of ISCR
• Supported the Company cross collaboration webinars conducted for PV awareness among HCPs by being in the core committee, preparing the initial contents for sharing, being the first speaker and then Chairperson for these monthly webinars conducted
• Has been awarded for her consistency in being compliant to the ever changing regulations and received accolades from her Global PV team for innovations within the function
TARUN B
Ipca Laboratories
TARUN B
Ipca Laboratories
TARUN BISWAS, Manager – Quality and Compliance (Pharmacovigilance), Ipca Laboratories
The best kind of experience in Quality Management Systems for manufacturing of Pharmaceuticals formulations for a wide range such as Solid Dosage Forms (Tablets, Capsules), Liquids, Powder, Injectables, Ointments, Cosmetics, Packaging, etc.. in Quality Assurance. Specialties: Validation, GMP, GLP, Qualification, Quality Compliance, Quality Control, Deviation & Change Control, CAPA, Handling product quality complaints and market complaints, Good Documentation Practices, Global reporting, regulatory as per USFDA, ANVISA, MHRA, MCC, TGA, WHO GMP, CDSCO, NDA, MCC, Quality Management Systems and tools.
Currently in Pharmacovigilance/Drug Safety, Strong Knowledge with cross-functional expertise in regulatory, safety, and quality, information management in Pharma Environment for USFDA, EU MHRA, EMA, PvPI-CDSCO, Medical Literature Monitoring, ICSRs, Embase, Pubmed, ASPR's, ARISg5, Argus 6.0/7.0/8.01/8.1.2, PSUR, PBRER, PADER, SPC, RMP, Eudravigilance, XEVMPD, GxP, assistance to QPPV, PSMF, PRAC, WHO, PvPI, CDSCO, Training, Documentation, Trackwise, LMS, QMS, Medico Regulatory Affairs, Audits, and Regulatory compliance monitoring, Post Market Surveillance, Regulatory Strategy. Also a good thinker.
WASIMUZZAMA K
Haleon
Explore drug safety – Improving PV Ecosystem over Quality, Safety, Signal Detection, RMP, REMS, Audits & Inspections, Prioritising Patients, Impact of Technology, Regulatory
Event Schedule
Meet and to network with your conference colleagues.
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
CHALLENGES AND OPPORTUNITIES
09:30 – Challenges in Outsourcing Pharmacovigilance
RAJESH RAJENDRAN, Director - Projects and Vendor Management Lead, Worldwide Safety, Pfizer
10:00 – DISCUSSION WITH EXPERTS: Analyzing challenges and barriers for better future of Pharmacovigilance
• What are the recent trends in GPP?
• Detecting and managing safety signals – what are the risks and new direction?
• Adverse event reporting – how devices make better things?
• Quality management and assurance in pharmacovigilance – what are the steps needed to take?
• How long can AI, process automation and improvements give a hand in PV?
• Global regulatory changes – how companies are handling them?
Moderator:
VIPIN SETHI, Global Head – Pharmacovigilance Head – Medical Affairs – ISBU, Cadila
Panellists:
SAKSHI SHRIVASTAVA DESAI, Associate Director International Pharmacovigilance Strategy Realization, Johnson & Johnson
ANUJA JAWALE, Associate Director RA and PV Strategic Sourcing and Vendor Management, Organon
INDU NAMBIAR, Local Patient Safety Lead, Boehringer Ingelheim
WASIMUZZAMA KHAN, India QPPV (PvOI) & Sr. SDEA Specialist, Haleon
TARUN BISWAS, Manager – Quality and Compliance (Pharmacovigilance), Ipca Laboratories
10:50 – Morning Coffee/Tea & Discussion
PATIENT SAFETY
11:10 – DISCUSSION WITH EXPERTS: Securing patient safety and monitoring in PV
• How to ensure the patient safety and quality of products concurrently?
• Electronic Health Records – Is patient’s privacy at risk?
• Key factor in the patient-centric approach in pharmacovigilance
• Role of technology in patient safety and monitoring
• Preventing patients from risk – what has to be done?
• Recent regulations that protects and ensures patient’s safety
Moderator:
DILIP PAWAR, Global Head - Medical Affairs and Pharmacovigilance, Unichem Laboratories
Panellists:
MUKESH GORI, Associate Director - ESP Management PV Operations, Novartis
UJWALA NAIK, Country Safety Head, Johnson & Johnson
MANGALA KOTNIS, Former Head Regional Medical Affairs, Abbott
PRASHANT BODHE, Director, CliniSearch
MANOJ SWAMINATHAN, Director - Safety & Pharmacovigilance, Biorasi (Former Head - Global Pharmacovigilance, Piramal)
12:00 – Technology: Unlocking the better ways in PV
• Digital Adverse event monitoring and Electronic Health Records – What are the risks and benefits?
• ML in patient monitoring: How do industrial experts see this?
• Regulatory decision – making: In what way AI makes the path easier?
• Data management and control in PV
• Solving the challenges in PV by using Cloud
SAKHARAM GARALE, Founder & CEO, Renovare Healthcare Solutions
12:30 –Networking luncheon
RISK MANAGEMENT
13:40 – DISCUSSION WITH EXPERTS: Planning for Future - Risk management and strategies in PV
• Potential analyzing of safety and risk signals in PV
• Strategies to minimize the risk measures – what are the new developments?
• How the data analytics will make a better way to avoid risks?
• Risk Evaluation and Mitigation Strategies(REMS) – new challenges and chances
• Stakeholders in REMS – Communications must be improved
• Improving quality management in PV and identifying risks
• Discussing about the strategies that support the PV from beginning to end
Moderator:
VISHWAS SOVANI, Founder Director, Pharmawisdom
Panellists:
JAMAL BAIG, Multi Country Safety Head, Sanofi
SIVA KUMAR BUDDHA, Global Phv Surveillance Physician Sr Manager, Teva
VALLABH DESHPANDE, Head of Global PV Operations, Glenmark
DEEPA ARORA, Chief Executive Officer, CLINEXEL Life Sciences
VRUNDA PANDYA, Deputy General Manager – Quality Assurance, SPARC
KAVYA KADAM, Consultant Global Clinical Trials
14:30 – Role of Central Laboratory in Safety Reporting, Data Collection, Prevention & in Clinical Trials
GOPAL NANDAN, Head - Clinical Trial & SR, Oncquest Laboratories
14:50 – Afternoon Tea/Coffee
REGULATORY
15:10 – Regulatory Intelligence – a tool to contribute Regulatory strategy and overcome challenges
• Introduction to Regulatory Intelligence
• Business needs
• Where it can contribute – Regulatory strategy, submission, Life cycle management, Quality, Pharmacovigilance etc
• Managing Regulatory Intelligence in the global context
POOJA THAKUR, Head Regulatory Intelligence & Reporting, Advanz Pharma
15:40 – DISCUSSION WITH EXPERTS: Opportunities and obligations in regulations
• New guidelines changes in GPP
• Current and future trends in PV regulations
• Regulations on adverse events
• Recent changes in drug regulations – How should companies handle the changes?
• Guidelines for critical medicines
Moderator:
MILIND ANTANI, Leader, Pharma and Healthcare, Nishith Desai Associates
Panellists:
K BANGARURAJAN, Adviser, CDSCO (New Delhi)
HARSHAD KOTHAWADE, Director, Head of Regulatory Management & Trade Compliance India, South East Asia, ANZ, Merck KGaA
RAHUL GUPTA, Sr.Vice President, Regulatory Affairs, USV
GEETA SHANBHAG, Vice President - Pharmacovigilance and Medico-regulatory Affairs, Ipca Laboratories
SADANAND KULKARNI, Head-Medical, Regulatory, Vigilance, Quality, Fresenius Kabi
16:40 - Chairperson’s closing remarks and end of conference
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Event Sponsors & Partners
Oncquest Laboratories
Over the 20 years, Oncquest Laboratories Ltd. has been synonymous with trust and confidence in the field of diagnostic services. Oncquest have a comprehensive test menu covering basic routine tests, specialized & super specialized tests, to highly advanced Genomic testing. Oncquest started as a research entity of Dabur Research Foundation way back in 2001 and has been a forerunner in the molecular diagnostics services across India and neighbouring countries.
A favourite amongst clinicians, specialty hospitals, and other path labs, Oncquest is known for second opinion and final diagnosis, using most advanced technology and skills.
Oncquest national footprint spans over 50 Laboratories, 400+ Collection Centres & 2500+ Service Associates. It conducts over 4,000 different tests - from the routine to the most complex, spanning over 200 technologies.
Oncquest has a highly skilled and globally reputed team of qualified doctors with combined experience of 600+ years. Its logistic capabilities and Pan Asia geographical spread makes Oncquest an ideal associate for all clinical activities.
Oncquest is promoted by the Burman family - the promoters of Dabur.
Visit our website: www.oncquestlabs.com
CLINEXEL Life Sciences
CLINEXEL is a full service CRO. We provide science driven customized, cost- effectiveand time sensitive efficient early phase clinical development solutions. We are providing end to end clinical trial, regulatory, pharmacovigilance and medical writing services to pharma, biotech and medical device companies.
CLINEXEL Senior Management have strong experience in large pharma and biotech companies therefore, understand the business needs and challenges of clinical development, and key aspects of life cycle management of pharmaceuticals.
We are supporting small and mid-size pharma and conducting Phase 1, 2 and 3 Clinical Trials for NCEs and Biologicalsand Pharmacovigilance regulatory compliance activities.
Visit our website: www.clinexel.com
GSS Pharma Services
GSS Pharma Services is an emerging provider of end-to-end pharmacovigilance services across the globe. We are known for long-term reliable partnerships with our clients. Our founding leaders are pioneers in pharmaceutical and pharmacovigilance industries with many decades of experience in establishing and maintaining Pharmacovigilance systems. Our service is powered by minds with decades of experience in pharmacovigilance and healthcare.
We provide the best price in the industry with an uncompromising attitude towards quality, compliance and patient data safety. Our services include but are not limited to ICSR processing, Global and Local Literature Surveillance, Medical writing (Risk Management Plan, PSUR/PBRER, Addendum to Clinical Overview, Clinical Expert Statements, Risk Assessment Reports), QPPV services, Maintenance of Eudravigilance portal, SmPC review, Medical Information Call Centre (MICC), Signal Management, Maintenance of QMS.
We use AI based modern software that focus on simplicity, efficiency and patient data safety. Our satisfied clients span over EU region, UK, Australia,New Zealand,and India. Our offices are located in Whitefield, Bengaluru, and London and thus we cater across time-zones. You are welcomed for a visit to any of our offices. Please also visit our website at www.servicesgss.com and to join our list of satisfied clients, drop an email to services@gsspharma.com.
Visit our website: www.servicesgss.com
Clinevo Technologies
Clinevo Technologies is an IT firm that provides regulatory compliance and user-friendly cloud-based Software Solutions for Clinical Trials and Drug Safety / Pharmacovigilance to over 100+ Pharma/CROs.
Clinevo solutions, through their Integrated Clinical Trial Platforms, can help Clinical Trial companies conduct Decentralized Clinical Trials and Virtual Clinical Trials in a highly efficient manner.
Clinevo Cloud-based software and databases have been validated by several international authorities, including the USFDA, EMA, MHRA, Health Canada, DCGI, and others, and meet regulatory requirements such as HIPAA, ICH, GxP, 21 CFR Part 11, Annex 11, GDPR, and others.
Clinevo Technologies has a reputation for delivering solutions faster than majority of providers in this domain. Furthermore, they offer cost benefits that are unrivalled!
Some of their cloud-based Software Solutions are listed below:
Clinical Trial Systems
• Clinical Trial Management System (CTMS)
• Electronic Trial Master File (eTMF)
• Electronic Data Capture (EDC)
• eConsent
• ePRO/eCOA
• Randomization / IWRS
Drug Safety Systems
• Pharmacovigilance Database with AS2 Gateway
• Signal Detection
• Case Intake with MICC and Web Intake
Quality Management Systems
• Document Management System (DMS)
• QMS – CAPA, Change Control, Deviations and Audit Management
• Training Management / eLearn
Visit our website: www.clinevotech.com
ClinChoice
Established in 1995, ClinChoice Inc. is a full-service CRO accelerating the development of cutting-edge drugs, medical devices, vaccines, and consumer healthcare products while supporting our client’s post-marketing operations for regulatory compliance and analysis. With over 20 offices spread in North America, Europe, and the Asia Pacific, we are a globally diversified workforce of about 3500 life science experts and specialists consisting of MDs, RNs, and PhDs in scientific streams.
Backed with substantial experience in supporting innovators of all sizes, our Clinical Safety and Pharmacovigilance division specializes in providing end-to-end services ranging from ICSR Processing, Global & Local Literature Monitoring, Aggregate Reporting, Risk Management, Signal Management, and PV Compliance services.
Visit our website: www.clinchoice.com
Techsol Life Sciences
Techsol Life Sciences specializes in offering full-range clinical research services for the clinical development of drugs, biologics, medical devices, and drug/device combination products across various indications. As a trusted scientific solutions provider, we partner with biopharmaceutical, biotech, and medical device companies to accelerate clinical development, navigate regulatory pathways to obtain approvals and provide post-marketing support throughout the product lifecycle. With our deep scientific knowledge across various therapeutic areas, we leverage our extensive site network and use innovative technology solutions to complete clinical studies, generate statistically sound datasets and timely complete regulatory submissions with an unwavering focus on process quality and patient safety.
As an ISO 13485 and ISO 14155 certified organization, we also specialize in delivering value-focused MedTech clinical services that includes regulatory lifecycle management, EU-MDR / IVDR consulting, medical writing, clinical investigations, biometrics, device vigilance, product certification, device labelling, artwork management and conducting different types of post-marketing and real-world evidence studies. Using our deep-domain scientific expertise, we help medical device sponsors to navigate through complex regulatory requirements, gather clinical and safety evidence, launch new products, and proactively perform post-market surveillance reporting across different classes of medical devices.
To know more about the Techsol Life Sciences ,
Email us on : info@techsollifesciences.com
Visit our website : www.techsollifesciences.com
Oviya MedSafe
Oviya MedSafe is a global Pharmacovigilance Consulting & Drug Safety Services company incorporated in India in 2012 and in the UK in 2014, providing end-to-end outsourced pharmacovigilance services to drug manufacturers and marketing authorization holders.
Oviya MedSafe also consults to emerging pharma/biotech companies and license-holders to establish and evolve their drug safety systems.
Visit our website : www.oviyamedsafe.com
Virtue Insight
CONCEPTUALISED BY
Virtue Insight
CONCEPTUALISED BY
Virtue Insight equips business professionals around the world with the latest indepth industry knowledge and provides networking opportunities in the telecom, infrastructure and pharmaceutical industry. Our aim is to provide a platform to share knowledge and insights and provide our event attendees to network effectively and deliver maximum ROI by make new business alliances. We strive to produce high quality conferences which include the latest topics which are delivered by world class leaders of the industry.
Our motto is to offer our customers the expertise and connections for a profitable business. Our events encompass an optimum chance to gain maximum value in terms of networking and an opportunity to sponsor and exhibit to attract new business alliances.
Testimonials
Syneos Health Global Safety & PV Associate
Lupin Senior Executive
Mega Lifesciences Assistant Manager – Pharmacovigilance
George Clinical MSA
IQVIA Associate Manager
Wockhardt Head – Medical Affairs
SYNORBS BIOSOLUTIONS Director
Qtech Solutions CIO
Cipla Medical Services
Fresenius Kabi Senior Manager
Glenmark Assistant Manager
Jeevan Scientific Technology Manager – PV
Ipca Laboratories Drug Safety Executive - Corporate Pharmacovigilance Cell
