O S SADHWANI FDA
K. BANGARURAJAN CDSCO
MUZAFFAR AHMAD Member, Strategic Advisory Board on Health Millenium Alliance (Govt of India) and Member Council of India
DEEPA ARORA Lupin
MANISH VERMA Sanofi
SARABJEET KAUR APCER Life Sciences
AMBRISH SRIVASTAVA Alkem Laboratories
VIKRAM GOTA ACTREC, Tata Memorial Centre
BHASWAT CHAKRABORTY Cadila
AVINASH R. KAKADE Cipla
SHUBHADEEP SINHA Hetero Labs
RAHUL GUPTA USV
JAMAL BAIG Merck Sharp & Dohme
PRAVIN GHADGE Reliance Life Sciences
SUJAY SURESH KULKARNI GSK
MILIND ANTANI Nishith Desai Associates
DEEPTI SANGHAVI Tata Consultancy Services
SRIDHAR YESHAMAINA Wockhardt
GURPREET SINGH Novartis
NIDHI VAISH DAS Roche Pharmaceuticals
MANOJ SWAMINATHAN Piramal
PRANJAL BORDOLOI Veeda Clinical Research
RAJANI ROKADE PharmaSoulz
PRASHANT BODHE CliniSearch
9th November 2017, Kohinoor Continental Hotel, Mumbai, India
“Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management”
- Conference Info
- Day One
- Sponsorship Opportunity
The Pharmacovigilance conference, organised yearly by Virtue Insight, is a unique event where key stakeholders gather with the aim of promoting patient safety and undertaking to continue work towards a more efficient pharmacovigilance system. In the spirit of constructive cooperation, this event brings together representatives from the industry and regulators as well as healthcare professionals and patient organisations.
In order to succeed in this new environment, it is critical to be up to date on legislation globally and be transparent in all PV process. We need to have effective systems in place to empower patients, physicians, drug manufacturers and consumers to make the best drug safety decisions.
14th Pharmacovigilance 2017 will bring together key thought leaders and experts to explore these worldwide challenges. This is your opportunity to engage and sit alongside the pioneers who are driving forward innovation in pharmacovigilance. Explore benefit-risk management strategies and patient-centric approaches; discuss how you can tackle the challenges of social media and drug safety legislation globally.
Morning sessions reflect on achievements so far and focus on the milestones ahead. An open dialogue between key stakeholders has proven to be the right approach for making significant progress towards better pharmacovigilance for better public protection. Traditional afternoon brainstorming sessions stimulate a lively, engaging debate incorporating all perspectives. Hot topics are debated to identify the best possible processes and tools leading to better access to high quality medicines in India.
It gives us immense pleasure in welcoming you to the 14th Pharmacovigilance 2017
KEY THEMES DISCUSSED AT THIS CONFERENCE:-
- PV legislation: What are the next steps? Reflections from the commission, IMA and the industry.
- How to improve pharmacovigilance activities?
- Creating a PV-focused culture
- How can you achieve pragmatism environment in today's PV?
- Pharmacovigilance and enabling technologies: which business model in a fast changing world?
- Opportunity that can reduce financial risk and increase effectiveness
- Pharmacovigilance Inspection Readiness
- Risk Minimization and effectiveness evaluation
- Business partners and exchange of safety data
- Optimising Drug Safety through Research Based Pharmacovigilance
- Launching a digital app in India for reporting ADRs: first results
- PV automation for data processing - Can Artificial Intelligence be trusted
- How social media can be used for pharmacovigilance syste
- Barriers to adopting AI and automation
- Patient view: the influence of real-time patient ratings and reviews of medicines and healthcare, and how this will shape the future of pharmacovigilance
- Proactively accomplish drug safety through patient engagement
- The challenges of the Indian Regulation – How to adapt and when?
- Required undergo registration process with CDSCO & DCGI
- Accelerating new medicine introduction in developing world & overcoming challenges
- Be part of a major networking opportunity
WHO SHOULD ATTEND:-
Vice Presidents, Directors, CRO’s, Heads and Managers of:
- Pharmacovigilance Strategy
- Drug Safety/Risk Management
- Information and Clinical Data Management
- Clinical Research
- Research & Development
- Product Safety/Assurance Assessment
- Patient Safety & Outcomes Research & Data Analysis
- Epidemiology project management
- Regulatory Affairs and Compliance
- Sales & Marketing
- Biotech manufacturers
From the following:
- Pharmaceutical organizations
- Generic pharmaceutical companies
- Contract research organizations
- Patient recruitment companies
- Government- Department of health
- Non-profit organizations/ Association
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 drinks 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.
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
09:20 – Chairperson opening remarks
MARKET OVERVIEW & ANALYSIS
09:30 – Topic TBC
O S SADHWANI, Drug controller of Maharashtra and Jt. Commissioner Drug, FDA
10:00 – Pharmacovigilance System Master File: Prime indicator of a robust pharmacovigilance system
• Expectations in EU from PV system master file (PSMF)
• Importance of effective Key Performance Indicators (KPIs): Measurement of PV processes
• Adoption of PSMF outside EU
SARABJEET KAUR, Associate Vice President- Pharmacovigilance, APCER Life Sciences
10:30 – Morning Coffee/Tea & Discussion
CHALLENGES & OPPORTUNITIES
10:50 – DISCUSSION WITH EXPERTS: Creating a PV-focused culture
- How digital health initiatives altered the monetization and accuracy of PV?
- Merging global PV system into the company corporate quality system
- How can you achieve pragmatism environment in today's PV?
- Challenges and solutions – function of PV in scientific literature
- Required legislation to screen scientific literature – how to regularly identify adverse drug reactions and other safety relevant information using software solutions? Can it contribute to solving these challenges?
- What are the challenges for dealing large amount of data, developing search strings and integrating IMA MLM results
- Implementation of additional risk management measures
- Mobile technologies and social media in pharmacovigilance
- GVP guidelines and how it can change your organizational performance and reporting.
- Discussing how the latest Pharmacoepidemiological approaches support risk management
- Discussing pharmacovigilance in vaccine development is in general using the same methods as in development of usual drugs
PRANJAL BORDOLOI, AVP - Medical Affairs and Pharmacovigilance, Veeda Clinical Research
SRIDHAR YESHAMAINA, GM - Global Clinical Development & PV, Wockhardt
MANISH VERMA, Director and Head of Medical Affairs, South Asia Zone, Sanofi
SUJAY SURESH KULKARNI, Senior Manager, Medical and Regulatory Affairs, GSK
PRAVIN GHADGE, Head - Medical Writing & Pharmacovigilance, Reliance Life Sciences
ADDING VALUE TO THE GLOBAL PHARMA INDUSTRY
11:30 – DISCUSSION WITH EXPERTS: Pharmacovigilance and enabling technologies: which business model in a fast changing world?
- Fast changing business environment - Pushing the stakeholders in the life science industry to look for different way to face business challenges
- Add substantial value to the pharmaceutical industry beyond its cooperation to be the custodian of patient safety
- Pharmacovigilance business, shrunk budgets, increasing data sources. How fast changing regulations are rising and what are the needs in the operators
- Challenges while expanding business expansion, raising corporate images, insuring financial security and envisioning scientific challenges
- How technology and information technology can enable the need to be compliant with the business changes? Are there “new or different” approaches to deal with pharmacovigilance services?
- Unbundling of PV services and PV platform management, Software as a Service vs. Hosting
- Opportunity that can reduce financial risk and increase effectiveness
- PV automation for data processing - Can Artificial Intelligence be trusted
- How social media can be used for pharmacovigilance system
PRASHANT BODHE, Director, CliniSearch
SHUBHADEEP SINHA, Vice-President & Head (Global) - Clinical Development, Medical Affairs & Pharmacovigilance, Hetero Labs
BHASWAT CHAKRABORTY, Senior VP & Chair, Research and Development Core Committee, Cadila
MANOJ SWAMINATHAN, Chief Manager / Head - Global Pharmacovigilance, Piramal
DEEPA ARORA, Vice President - Pharmacovigilance & Global Head - Drug Safety & Risk Management, Lupin
NIDHI VAISH DAS, Drug Safety, Roche Pharmaceuticals
12:10 – Business partners and exchange of safety data
- Organising and developing, sales, marketing, safety handling, regulatory matters, phone centres and manufacturing for vendors to handle development.
- Safety exchange agreement – Necessary act to cooperate with health authority demands
- Direction and instructions to all involved organizations with regard to their responsibilities for drug safety.
- Ensuring all associates receive the safety documents they need to remain in full compliance with all regulatory and legal requirements in their jurisdictions of sale or study.
- Adequate signalling and benefit to risk analysis
- Is the data ready for a corporate audit or health authority inspection?
12:40 - Networking luncheon
Afternoon Chair Person
13:40 – Self-inspections in Pharmacovigilance
- Relevant regulations & Expectation of authorities
- Strategic planning to meet regulatory requirements
- Selecting auditors- ensuring compliance
- Risk based approach- Developing the most appropriate check list
DEEPA ARORA, Vice President - Pharmacovigilance & Global Head - Drug Safety & Risk Management, Lupin
14:10 – PANEL DISCUSSION WITH EXPERTS: Risk Minimization and effectiveness evaluation
- Risk management plan – Challenges and Opportunities
- Detailed practices in risk minimization
- Insights to effectiveness evaluation from both regulator and industry perspective
- The guidelines for risk management plans (RMPs) and how to develop it?
- What are the expectations of the PRAC? How it is assessed by the authorities?
- What are the main weaknesses of the RMPs provided by the license holders and how to improve them?
- Benefit-Risk Assessment in PSUR: Discussion on Practices
- What are the current regulatory and practical challenges of the Risk Management Plan and can potential improvements be identified?
- Pharmacovigilance Inspection Readiness
- PV Outsourcing Landscape - Changing dimensions from Service Provider to Partner
RAJANI ROKADE, Founder-Director, PharmaSoulz
VIKRAM GOTA, Associate Professor, ACTREC, Tata Memorial Centre
GURPREET SINGH, Head of Vendor Management in PV, Novartis
AVINASH R. KAKADE, Senior Director and Head of Pharmacovigilance, Cipla
DEEPTI SANGHAVI, Assistant Manager-Medical Writing, Tata Consultancy Services
14:50 – Topic TBC
MUZAFFAR AHMAD, Member, Strategic Advisory Board on Health Millenium Alliance (Govt. of India) and Member Council of India
15:20 – Changing safety legislations: New challenges for license holder
- GPV guidelines – India
- RMP changes – EU
- Overview of PV regulations in APAC
JAMAL BAIG, Country Head- Pharmacovigilance, Merck Sharp & Dohme
15:50 – Afternoon Tea/Coffee
16:20 – The challenges of the Indian Regulation – How to adapt and when?
- Challenges faced in Indian market as compared to the global market
- How to work with regulators to optimise timelines for drug approvals?
- Regulatory updates on submission, approval, harmonization, new policy and speed in licensing
- Overview on how to educate for the future regulatory surroundings/outlining the result obligations for the manufacturer, including: Classification/ PSURs/ Post-market surveillance system/ Clinical evaluation report.
- Signal detecting and management – New process and overview
- Is the legislation on new Indian Medical Devices Regulation (MDR) are in final phase?
- Required undergo registration process with CDSCO & DCGI
MILIND ANTANI, Partner In-Charge - Pharma LifeSciences, Nishith Desai Associates
AMBRISH SRIVASTAVA, Vice President: Medial Affairs, Clinical Research & Regulatory, Alkem Laboratories
K. BANGARURAJAN, Deputy Drugs Controller, DDC(I), CDSCO
RAHUL GUPTA, Vice President, Regulatory Affairs, USV
17:00 – Chairperson’s closing remarks and end of conference
17:10 – 18:00 – Networking Drinks Session
O S SADHWANI
Drug controller of Maharashtra and Jt.Commissioner Drug
Deputy Drugs Controller, DDC(I)
Dr. K. Bangarurajan did his Degree in Pharmacy from Madras Medical College and M. Pharmacy from Banaras Hindu University, Varanasi in the Year 1984 and was awarded Ph.D. by Tamil Nadu Dr. MGR Medical University in the Year 2000.
He began his career as a lecturer at J.S.S. College of Pharmacy, Ooty.
He joined the Drugs Control Department in the Year 1986 as a DRUGS INSPECTOR and served as a Senior Drugs Inspector and Assistant Director of Drugs Controller.
He was awarded as "Best Drugs Inspector" in the year 2005.
He joined the Central Drugs Standard Control Organization, Headquarters at New Delhi in the Year 2010 and since 24th February 2014, he is posted at Central Drugs Standard Control Organization, West Zone, Mumbai. He has the overall charge of the Western region and responsible for uniform implementation of the provisions of the Drugs & Cosmetics Act and rules thereunder.
He has made remarkable contributions in National and International seminars, workshops, which shows his urge for upgrading knowledge of the complex pharma spectrum which undergo rapid changes.
Member, Strategic Advisory Board on Health Millenium Alliance (Govt of India) and Member Council of India
Vice President - Pharmacovigilance & Global Head - Drug Safety & Risk Management
Director and Head of Medical Affairs, South Asia Zone
Associate Vice President- Pharmacovigilance
APCER Life Sciences
Vice President: Medial Affairs,Clinical Research & Regulatory
Working with Alkem Laboratories Ltd as Vice President – Medical Affairs, Clinical Research & Regulatory. After completion of MD in clinical pharmacology worked as Asst Professor in Lady Harding Medical College New Delhi for about 5 years. Worked in various Indian and Multinational pharmaceutical company since last 25 years in the area of Medical Affairs and Clinical Development including NCEs, Generics and Biological drugs.
Participated in several National and International medical conferences as speaker on several diseases and drug therapy. He is a guest faculty in several Institutions and research centres in the area of clinical research and drug development.
Life Member of Indian Medical Association (IMA),
Life Member of Research Society of Study in Diabetes in India (RSSDI).
Member of International Society of Pharmacovigilance
He has about 40 publications in Indian and International medical journals. He has been awarded Vishisht Chikitsa Medal in 1994 by Governor of Andhra Pradesh and Rashtriya Ratan Award in 2005 by Governor of Gujarat for community health.
ACTREC, Tata Memorial Centre
Senior VP & Chair, Research and Development Core Committee
Dr. Bhaswat S. Chakraborty graduated with a B.Pharm. (Hons.) from Banaras Hindu University and a PhD in Clinical Pharmacology from University of Saskatchewan.
Following his post doctoral fellowship and a brief spell of teaching at University of Saskatchewan, Saskatoon, Canada, Dr. Chakraborty joined the Health Protection Branch, Ministry of Health, Government of Canada (Canadian FDA) in Ottawa and served as a Senior Clinical Reviewer and Acting Department Head of the New Drug Applications. In this role, he has evaluated more than 300 Abbreviated New Drug Applications and 20 Pharmacokinetics based New Drug Applications.
Thereafter, he was the Director of Biopharmaceutics at Biovail Corporation International, Toronto. Till date, he has designed and investigated ~624 Phase I and 62 higher Phase Clinical Studies for the FDA, TPP, EU and other Agencies.
Recipient of many prestigious research grants, Dr. Chakraborty is currently the Senior Vice President and Chairman of Research & Development Science Core Committee at Cadila Pharmaceuticals Ltd., Ahmedabad. He is also an author and co-author of more than 100 scientific papers and abstracts in refereed international journals.
An eminent speaker, Dr. Chakraborty is an Honorary Professor and External Examiner to a few universities; editorial board member of three international journals; reviewer of many professional journal manuscripts, and also on the board of several Institutes and Universities in India and USA in various capacities. He has supervised 24 Masters’ and 5 PhD students
AVINASH R. KAKADE
Senior Director and Head of Pharmacovigilance
Vice-President & Head (Global) - Clinical Development, Medical Affairs & Pharmacovigilance
Vice President, Regulatory Affairs
Country Head- Pharmacovigilance
Merck Sharp & Dohme
Area of Interest: Drug Safety and Pharmacovigilance, Regulatory Affairs, Cardiovascular Pharmacology.
Had been associated with Kasturba Medical College and Hospital a Regional Centre for Pharmacovigilance in 2003 and was responsible for reporting ADRs to National PV center at AIIMS , this program later on became the PvPI in 2010.
Have held teaching faculty position at the NIPER (Premier institute of pharmaceutical education in India).
Have worked in Wipro Ltd- setting up of Pfizer Drug and Safety outsourced project in India as a Team Lead and Pharmacovigilance trainer, SME for case intake, data entry , case processing and quality control.
For last 07 years working as Global Safety (Pharmacovigilance and Clinical Risk Management) country leader at Merck Sharp and Dhome ( MSD) Pharmaceuticals Pvt Ltd. In the current role oversee the entire PV operations in India, Pakistan, Bangladesh, Nepal, Sri Lanka, Maldives and Bhutan, which includes the PV responsibilities in the area of Clinical Trials, PMAS, Aggregate reports , Patient support programs, Health agency engagements, PV vendor qualification, SDEAs and collaboration with business partners.
Have been session chair in DIA India 2016 conference, speaker at Indian Pharmacovigilance day 2016, confirmed speaker 7th Annual Pharmacovigilance Asia Summit (20-21 September 2016).
Recently from Industries end played a key role by leading the IPC-PvPI initiated drafting the Post Marketing PV Guidelines in India, the guidelines were published on 30 Sep 2017.
Head - Medical Writing & Pharmacovigilance
Reliance Life Sciences
SUJAY SURESH KULKARNI
Senior Manager, Medical and Regulatory Affairs
Dr Sujay Kulkarni is a Pharmaceutical Physician with 14 years of pharmaceutical industry experience in the fields of Medical Affairs, Clinical Research, Pharmacovigilance, Medical writing, and Regulatory affairs.
His area of interest is Clinical Drug development with focus on anticancer and anti-inflammatory molecules. His therapeutic areas of expertise include Oncology, Pain, Immunology, and Dermatology.
He has in- depth experience in 'drug development process' (Phase I-IV) including clinical trial management; interactions with regulatory authorities (Health Canada, US FDA and Drugs Controller General of India); and drug safety surveillance. He has vast experience in conceptualizing, implementing, and managing clinical programs to meet the project objectives across North America, Australia, and India.
In his present assignment as Senior Manager, Clinical Research and Pharmacovigilance with GlaxoSmithKline Pharmaceuticals (GSK), Dr Sujay is responsible for managing scientific and operational activities of clinical studies conducted by GSK, India and for pharmacovigilance activities.
Prior to working with GSK, Dr Sujay was working with Piramal Research Center and was part of global drug development team, which was involved in early development (Phase I & II) of anti cancer molecules (Melanoma and Multiple myeloma) and in bench to bedside development and launch of anti- TNF alpha molecule for the treatment of Psoriasis.
He has published many scientific papers in national and international indexed journals and presented numerous abstracts in various international conferences including American Society of Clinical Oncology (ASCO), American College of Rheumatology (ACR), and American Academy of Dermatology (AAD). In 2010, he made an oral presentation at 68th annual meeting of AAD on results of phase II clinical study of molecule developed by Piramal Research Center for treatment of Psoriasis.
In the second half of 2016, working with Save the children, Vietnam on malnutrition project in children from ethnic minorities from mountainous regions of North Vietnam, Dr Sujay successfully completed comprehensive epidemiological study to evaluate malnutrition rate, worm infection rate, and relationship between water access, sanitation, and hygiene and malnutrition in children aged six to fifty nine months (six month international PULSE assignment – GSK collaboration project with Save the children).
In 2002, he received Young Investigator Award for the best Scientific Research paper by Indian Society of Clinical Pharmacology & Therapeutics at Associations of Physicians of India conference 2002.
He holds Doctor of Medicine in Clinical Pharmacology from Mumbai University and Diploma in Pharmaceutical Medicine by Faculty of Pharmaceutical Medicine, Royal College of Physicians, London. He is a certified Project Management Professional (PMI, USA) and currently pursuing Accelerated Devel
Partner In-Charge - Pharma LifeSciences
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.
He has authored and co-authored many articles, publications related to the pharma and healthcare industry including a book on CRAMS, and Pharma and Life science. The have also contributed a chapter on India in ‘Commercialization of Healthcare-2nd Edition Global Guide’ published by Thompson Reuters in 2015. He is a regular speaker and panelist at various national and international forums on the subjects of pharma, biotech, IP, clinical trials, healthcare, CSR, FCRA. He is also a visiting faculty at many institutions in Mumbai.
He has been included as one of the world's leading practitioners in ‘Who's Who Legal’ for Life Sciences 2014 and 2015 in the ‘Regulatory’ section as only lawyer from India.
Dr. Antani practiced as an ENT surgeon for 14 years prior to joining Nishith Desai Associates as a lawyer.
He has also successfully attended "Managing and Transforming Professional Service Firms-India” an executive training program organized by HARVARD BUSINESS SCHOOL.
Assistant Manager-Medical Writing
Tata Consultancy Services
Dr. Deepti Sanghavi has more than 10 years of experience in clinical research which includes medical writing and project management experience, handling studies across different therapeutic indications and phases. Currently, she is leading a team in Tata Consultancy Services. Previously, she has worked in Quintiles, Wockhardt & Siro Clinpharm in different niche areas like handling Thorough QT & biosimilar studies, drafting and reviewing protocols, clinical study reports, and publications; conceptualizing study designs, engaging in proposals, contracts/budgets, regulatory submissions, site monitoring, training & mentoring. Dr. Deepti has been a speaker in national/ international conferences, and has been involved in training several students on various clinical research topics.
GM - Global Clinical Development & PV
Dr. Sridhar has more than 16 years of experience in Global Clinical R&D in various therapeutic areas and has served leading positions in Novartis, Bharat Serums, Vivo Bio, SciTech and GVK. Currently he is the General Manager at Wockhardt Global Clinical Development & Pharmacovigilance leading Biosimilar’s and complex ANDAs portfolio. He is trained pharmacologist with a doctorate in Clinical Pharmacology and Therapeutics from Nizam’s Institute of Medical Sciences, Hyderabad.
Dr Sridhar has involved in various facets of drug development from basic to clinical research development strategies including drug safety. He has vast experience in early development studies in various dosage forms and dose ranging studies. He along with his team achieved many milestones successfully in various phases of global clinical development. He travelled across globe and He has published over 45 peer reviewed publications, made more than 100 presentations at national and international symposiums. He has authored 6 book chapters on topics related to Clinical Research and Cardiovascular Function. He is invited speaker at various national and international conferences viz., FIP, IPC, IPS, ISMS and ISCR etc. He is the recipient of young scientist award, Prof. U.K Seth National award for best clinical research in 2008 and subsequently received many other awards for excellence in drug research and development.
Head of Vendor Management in PV
“Gurpreet is currently the Head of Vendor Management for Patient Safety at Novartis and has a total experience of 12 years of which the last 11 years have been in Pharmacovigilance.
In the past he has worked in Service Provider Organizations like Cognizant and Tata Consultancy.
During his tenure he has worked in multiple roles including in Operations, Transitions, Business Development, Product Management, Project Management & Quality Management
An avid sportsman he is a long distance runner and cyclist.”
NIDHI VAISH DAS
Chief Manager / Head - Global Pharmacovigilance
Manoj is a physician with post-graduation in public health and has over 12 experience in Patient Care, Public Health Research and Global Pharmacovigilance Operations. Manoj is a drug Safety Professional with experience in various domains of Pharmacovigilance including academic/ training, vendor management and in-house Pharmacovigilance. He has a significant expertise in Pharmacovigilance integration following Mergers and acquisition. In the past, Manoj had been in a leadership role in Global Pharmacovigilance Operations at Sun Pharma and subsequently Bristol Laboratories UK. Presently Manoj is working as Head, Global Pharmacovigilance at Piramal Enterprises where he is handling a portfolio of over 140 countries.
AVP - Medical Affairs and Pharmacovigilance
Veeda Clinical Research
Dr. Bordoloi is a medical graduate with a MD in Clinical Pharmacology and a Post Graduate Diploma in Business Management. He has over 16 years of experience of working with Hospitals, Pharma – Biotech companies and CROs of global repute, where he had played key roles in Clinical Trial Management, Medical & Regulatory Affairs and Pharmacovigilance.
Dr. Bordoloi has successfully lead designing, strategizing and execution of various projects in drug development domain starting from preclinical studies to post marketing safety monitoring, this also includes over fifteen Biosimilars molecules. He was also part of the team for 1st Biosimilar registered from India in Europe.
Prior to joining Veeda CR, he has worked for companies like Cipla, Ethypharm, Intas, Jubilant and Lambda Therapeutic Research Ltd.
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
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
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
Indian Institute of Toxicology, Pune, India; Apr. 1988 - Oct. 1991
- Life member of ACTREC Alumni Association, Tata Memorial Center, Kharghar, India
- Indian Pharmaceutical Association (Life Member)
- Registered Pharmacist (Life)
- 13 scientific papers in indexed International (4) and National publications (9)
- Presentations: http://www.slideshare.net/PrashantBodhe
APCER Life Sciences is committed to improving health in partnership with its clients. They bring together safety, medical, regulatory, and technology resources to ensure that patients receive the safest, most effective therapies possible.
To achieve this mission, APCER Life Sciences has built a strong foundation. Their global infrastructure of scientific and medical experts, supported by integrated processes and regulatory-compliant technology systems, has proven to be responsive and scalable through exponential growth since our founding in 2007
Services: Safety, Medical Information, Medical Writing, Medical Affairs, Regulatory Affairs, Quality and Assurance, Technology
Please let me know if you need something else from my end.
Cliantha Research Limited
Cliantha Research Limited is an independent global Contract Research Organization (CRO) providing complete clinical research services. Our integrated clinical offerings includes Phase I/IIa, IIb, III and IV, Bioavailability/Bioequivalence (BA/BE), Clinical Endpoint Trials, Bioanalytical, Biosimilars, Biometrics (including CDISC), Pharmacovigilance and Personal Healthcare services.
Our group companies includes Hill Top Research (US, Canada), Karmic Lifesciences LLP (India) and Inflamax Research (Canada), and as one company Cliantha, we deliver high quality clinical services. Cliantha holds accreditations & approvals from the most respected regulatory agencies including USFDA, EMA, MHRA, TGA, MCC, DCGI, ANSM, AGES, Health Canada, and CAP. In the recent Global Data report - "A Steady Growth of Biosimilars in Clinical Investigations: A 10-Year Retrospective, 2007–2016" published in April 2017, Cliantha secured 4th position based upon the number of Biosimilars trials over a 10-Years period.
Safety for All – is our prime motto in providing Pharmacovigilance services. We offer end-to-end & customized Pharmacovigilance services for Medicinal Products, Medical Devices, Human Vaccines, Cosmetic Products, Herbal Products and Veterinary Products. All our services are in compliant to applicable regulatory requirements and have implemented industry adaptive safety database. We believe in delivering quality services in timely manner.
Elsevier provides information and analytics that help institutions and professionals progress science, advance healthcare and improve performance for the benefit of humanity.
We are a global leader in scientific data and analytics, offering comprehensive drug safety data sources and extensive experience alleviating challenges with pharmacovigilance processes. Our pharmacovigilance solutions — QUOSA PV, Embase and PharmaPendium — are used by practitioners to achieve pharmacovigilance with less pain and more efficiency.
We help our customers:
• Quickly detect adverse event information across various types of scientific literature
• Automate and centralize information monitoring and triage with detailed audit trails
• Use more effective information search strategies
• Generate audit-ready reports
• Track progress and manage workload of literature review staff members
• Access FDA/EMA drug approval and comparative drug safety data
Jeevan Scientific Technology Limited
Jeevan Scientific Technology Limited (JSTL) is an Independent Contract Research Organization offering complete Clinical Research Solutions supporting Pharma and Biotech companies.
Under Clinical Research division, JSTL offers comprehensive Pharmacovigilance Solutions starting from clinical development to post marketing product support, which includes
• Aggregate safety reporting
• Risk management strategy
• Signal detection
• Medical call centre
Drug Safety experts at JSTL continuously assess the safety of your products and define the best possible risk management, complaint to regulatory authorities.
A team of healthcare professionals with extensive knowledge on drug development process support our Drug Safety experts to offer deep expertise and operational excellence.
JSLT has licensed safety database, which provides client to Go Live at any point of time. We track the progress of the projects on daily basis using tracking tools developed by JSTLs in-house team.
In addition to Drug safety solutions, JSTL provides tailor made integrated Pharmacovigilance solutions, which includes
• Complete Pharmacovigilance system set-up
• SOP development
• Training to the staff
• Provide assistance during the regulatory audits.
JSTL is committed to patient safety and is open to unite with clients ensuring regulatory compliance without increasing the fixed cost.
We at JSTL, assist our clients with onsite and offsite business models, depending on client requirements.
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.
LEX WITNESS – India’s 1st Magazine on Legal & Corporate Affairs
LEX WITNESS vows to be a high quality monthly magazine with the powers of fresh and original content that would deal exclusively with subjects pertaining to legality. Country's top notch practitioners and experts are being invited to contribute in WITNESS with what we feel is relevant to all stakeholders in this profession, aiming at brainstorming between the legal luminaries and hence bettering this practice in all its aspects.
Events High is a marketplace where consumers can discover all events and activities at one place, organised by location, interest and social circle. While the team started prototyping the idea in July 2014, the business was incorporated only in November 2015. For over a thousand events happening every week in a city, the organizers use Events High’s CRM to sell tickets, promote their events to the right audience and manage their end-to-end workflow for digital presence.
Delegates booking is also available on Events High
Clocate.com is a leading international directory for worldwide conferences and exhibitions. Clocate.com is equipped with a unique and comprehensive search that helps you find easily any event in any category or location. Each event includes detailed information, like, description, dates, location, map, prices, link to the official event's website and more...
If you search for a conference or exhibition in areas such as Industry and manufacturing, Health and medicine, Technology and IT, Business and finance, sciences, education, services (banking, insurance, tourism, Hospitality and more), government, environment, life style and arts, you'll find it in Clocate.com.
Partnering with Virtue Insight means more than making the right contacts. It means being an insider. It means being connected to the right people with the right level of influence, and it means you are allied with a globally respected organization and leaders in the industry.?
Sponsorship, exhibiting and advertising packages are designed to provide a solid platform to help you stand out and make an impact. Our programs allow you to achieve your marketing goals and deliver a maximum return on your investment. We have developed convenient and customizable packages to help your organization meet its objectives and reach your target market.
Why Sponsor / Exhibit:
MARKET SHARE: Defending and Increasing Market Share
COMPETITION: To attach and defend against competition
- Generating sales leads
- Build brand image
- Maintaining customer relations
- Consolidating business relationships
- Accessing new and emerging markets
- Obtaining technical knowledge
- Leverages the events extensive marketing campaign to add value to your organisations marketing strategy and budget leading up to the event
- Live product demonstration to test market responses
- Facilitating quick market penetration
- Reach important targeted commercial prospects face to face in a social, relaxed environment. The ideal platform to build strong business friendships Strengthen your market position
Our conferences offer not only a unique combination of benefits (as listed above) to enable the sponsor/exhibitor to communicate the message but also a major opportunity that other forms of selling or media cannot provide.
Contact Us Today
Email - email@example.com
Email - firstname.lastname@example.org
Tel: +91 44 64536444
Our highly researched conference agenda delivers all the latest information and our world-class speakers attract delegates from around the world to attend. We aim for our attendees to be equipped with knowledge of latest developments and enable them to network with the industry key personnel.
What is the format of our conference programme?
The conference programme consists of world-class keynote addresses, case study presentations and panel discussions.
What are the benefits of attending?
- Meet your peers in an interactive, discussion-based format designed to maximize knowledge transfer and networking
- Enjoy our informal networking at drinks and lunch
- Meet the leading solution providers in the market to forge partnerships and discover solutions
- Receive electronic versions of the conference documentation for use of reference post-event.
- Get ideas for?training topics?that you might want to present as professional development sessions to others in your workplace.
- Observe speakers from the perspective of seeing what works really well so you can learn new public speaking techniques and strategies that you can apply when doing your own presentations.
- Learn what not to do in presentations if you end up sitting through any sessions that fail to be engaging or informative.
- Delegates also benefit from discounted rates onfuture event attendance
For more information or to register at the event please contact us TODAY:
Contact Us Today
Email - email@example.com
Email - firstname.lastname@example.org
Tel: +91 44 64536444
Standard Price – 1 or 2 Delegates - (INR 7,000 + GST (18%) per delegate) - You can simply email or call and book your conference delegate seats on TEL: + 91 44 64536444. Email – email@example.com
Group Discounts – 3 or 4 Delegates - (INR 6,500 + GST (18%) per delegate)
Group Discounts – 5 and above Delegates - (INR 6,000 + GST (18%) per delegate)
Spot Registration on the day of the Conference – 1 Day Conference - (INR 8,000 + GST (18%) per delegate)
Conference Sponsor & Exhibition Stall – Should you wish to Sponsor, or purchase a Exhibiton Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to – TEL: + 91 44 64536444. Email - firstname.lastname@example.org
Kohinoor Continental Hotel
Address: Andheri Kurla Road, Andheri ( E ), Mumbai 400059 - India
Phone: 91 22 66919000 / 91 22 28209999
Testimonials from our past Pharmacovigilance Conferences
Thanks Virtue Insight Piyush Patel for providing the stupendabulous experience of 13th Pharmacovigilance Conference in Chicago (27-28 Sep). Really worth attending this platform which constituted of wonderful people of the industry around from brilliant experience and background. Very well planned and coordinated; flawless activities all 2 days long. All the best to you and the team for events ahead. – Region Head, Business Development and Program Delivery, Turacoz Healthcare Solutions
Content very relevant. I learnt many things / got clarification on several points. – Sr. Manager PVCompliance, Gilead Sciences
Actually, I need only one word for the feed-back and testimonial: EXCELLENT.
To be a bit more specific, I would like to mention that the conference was very well organized, from preparation, communications, venue-selection, agenda, all the way to the food and networking mixer.
The selection of experts was well-mixed across the field yet focused on the subject of the conference, ensuring a lively and fruitful exchange of ideas.
The size of the conference was perfect for valuable discussions in the meeting and around it, and for highly meaningful networking.
The atmosphere of the conference was focused yet relaxed, making this at the same time a very valuable learning and networking opportunity and a pleasure to attend.
Thank you very much for bringing me to this excellent conference, it was an honour, a pleasure, and a very valuable learning and networking experience.– Director Clinical Cytometry, Biomarker Technologies, ECTR, Bristol-Myers Squibb
Good efforts, well organised, experienced speakers, current and concrete topics. Promises delivered – Pharmacovigilance Manager, Cheplapharm Arzneimittel GmbH
A lot of interesting topics – Global Compliance and Quality Director, Kantar Health
Well organised, Thank you – Senior DSA, Covance CAPS
The content of the conference is always good. Good to see speakers from regulatory authorities. Always delighted to attend your conference – Medical Services, Cipla
Conference was very informative & added much knowledge about Pharmacovigilance systems, ADE, process flow of reporting, searching data & mobile networking – Asst. Manager Regulatory Affairs, Emcure Pharmaceuticals
Well arranged and good interactive crowd – AVP - Medical Affairs and Pharmacovigilance, Veeda Clinical Research
Yes, it is good platform to understand the current industrial practice & the thought process – Assistant Manager, Clinical Research & Pharmacovigilance, Bharat Serums And Vaccines
Very good coverage of the area of PV – Safety Physician, Sciformix Technologies
It was a good learning experience – Team Leader, Cognizant Technology Solutions
Good platform to know about peers in the industry and for knowledge sharing – Pharmacovigilance Associate, Quanticate
Over all the conference was helpful – Senior Director - Clinical, Aris Global Software
This kind of conference is very important for younger generations and professionals to get mere awareness and day to day updates in markets – CIO, Qtech Solutions
A commercial knowledge venture explored several areas under the topic. Very good and Professional speakers. Over all more than satisfaction – Director, SYNORBS BIOSOLUTIONS
Panel discussions are very interactive as well as address real world and practical issues – Head – Medical Affairs, Wockhardt
I deeply appreciate the way you have organised the 11th Pharmacovigilance 2016. I would like to congratulate the whole team of virtue Insight for successfully organizing this meet. I am delighted to have participated in the meet, I had the opportunity to interact with field experts and totally i had a wonderful experience being their. Your team work was well established and everything was in place. The way you have organised the lectures and discussion on the floor is deeply appreciated. My Best wishes to the whole team of Virtue Insights – Director, SYNORBS BIOSOLUTIONS
The 9th Pharmacovigilance 2015 conference was a very thought provoking day. The content of the conference was great; experienced, talented speakers and size was enough for really good conversations. I have enjoyed the whole conference. My brain was both stretched and strained – never exhausted - Senior Manager - Regulatory Operation, Medical Affairs Wockhardt Limited
Very good platform to meet other pharmacovigilance expertise and interact with them about the advances & opportunites in pharmacovigilance. Virtue Insights is really good at coordinating and organizing - Safety Physician, Sciformix
It was very good conference. Thank you very much for offering me a speaker position. Keep up the good work and all the best for future conference - Head Pharmacovigilance, Wockhardt
End to end PV process discussion would be more helpful - Medical Writer, Parexel
It was really helpful in the terms of sharing knowledge - Drug Safety Specialist, Cipla
Very well organized and the sessions were so well placed. Got enough time for networking and well time managed - Country Safety Lead, Pfizer Limited
This conference is very useful for my work. I expect that every year Virtue Insight will organized this kind of conference - Research Scientist, Alembic Pharmaceuticals Limited
“The whole session was more lively and in particular the panel discussions” - PV Lead & Deputy QPPV, Auden Mckenzie (Pharma Division)
I liked the variety of presentations - Vice President - EU QPPV, The Medicines Company
Chairman was excellent. Speakers all delivered great talk. Great discussions, exchange and brainstorming was very useful - Associate Director, Global Drug Safety & Risk Management, Celgene Europe
Very Insightful – Speakers were very knowledgable - Manager, Results healthcare
Topics deliberated on social media were a good break from usual topics at pv conferences. A good line up of speakers - Consultant, Adamas Consulting
Well thought topics, very interactive session - Principal Consultant, Adamas Consulting India
Good informative and knowledge sharing session - Manager, Ranbaxy
A very good platform where cream of the Pharmacovigilance field of Indian pharma shared their views/opinions on involving of Pharmacovigilance trends & how to improve pv in India - Business Development Associate, Techsol Systems India Pvt Ltd
Informative session focusing on new and grey areas of Pharmacovigilance patient care being the utmost priority on minds of all the pharma company new aspect discussion and light on the grey areas had open new arena for Pharmacovigilance
thank you - Drug Safety Associate, Cipla
Well organized - focused on relevant topics - excellent choice of speaker’s food for thought - Head Pharmacovigilance, BMS India
The conference was well organized Content and quality of discussion were more informative. Thank you Virtue Insight - Head Pharmacovigilance, Wockhardt
I would truly like to appreciate the efforts and initiative of Virtue Insight in organizing this PV dedicated conference. I think its one of its kind in India, where the meeting is focused only on Pharmacovigilance. Kudos to the team for the well- organised and well –planned meeting. Its one event resulting in the confluence of PV personnel, networking and exchange of knowledge. Keep up the good work. Thanks and good luck - Head - Pharmacovigilance, Bristol-Myers Squibb
The panel discussions did truly impart knowledge - Deputy DSR, Novartis
This conference was very good for the pharmacovigilance professionals as well as business people. Organising this event and the event management was nicely done by Virtue Insight - IT Administrator, Oviya Med Safe Pvt. Ltd
The conference was interesting and was a good platform for networking. The audience and the panelists were from varying backgrounds giving an insight to various challenges being faced by the Indian industry - Manager- BD, ELC Research
Virtue Insight has established a niche for iteslf in the world of pharmacovigilance events held in India. The progressively increasing attendance from all stakeholders of Drug safety serves as a testimony to this - MD & CEO, Oviya Med Safe Pvt. Ltd
Good insight into Indian Pharmacovigilance scenario. This should happen regularly to keep the concerned updated - Team Manager, Cognizant Technical Solutions
The conference here was a good platform for discussing pharmacovigilance challenges in India and knowledge sharing with respect to pharmacovigilance - Officer Global PV, Sun Magma
Conference on pharmacovigilance was very specific to the subject and was managed well in terms of sessions held throughout the day - Associate Director, PV Delivery, Sciformix
It was indeed a rich learning experience. Hope it will continue in the future - Gayathri Subramani, Pharmacovigilance Associate, Oviya Med Safe The overall conference was informative. 3rd Annual Conference has actually started addressing the practical, day to day issues coming in the way of industrial PV solutions are disscussed - Regulatory Affeirs, Inventia Healthcare
Very nice conference - Executive - Medical Affairs, Johnson & Johnson
A well-organized conference that provides value for money not only the session, but the networker opportunities provides were very useful for building companies like Oviya Med Safe - Founder & CEO, Oviya Med Safe
The conference was very informative - Sr. CRA, Clininvent Research Pvt . Ltd
Very well organised Conference with speakers having appropriate expertise and adequate enthusiasm to dissipate acquired knowledge - President R&D, FDC Ltd
The Conference was a good platform for getting views about Pharmacovigilance practices across pharma companies - Asst. Manager - Medical Affairs, Wockhardt
Very enlightening subject specific. Good mix of delegates from industry and academics - Senior Executive - Clinical Research, Wockhardt
Worth Attending ! Loved the experience! - MSC Clinical Research, ICRI - Ahmedabad
Very Informative sessions - CSO, Boehringer Ingelheim
The Panel Discussion were highly informative and Interesting. It was great learning experience & foundation for organisation who are in the process of setting up their PV systems. We look forward for more such support - Senior Manager - Regulatory Affairs, Inventia Health Care
"The conference was indeed a great experience.Both the presentations and the panel discussions/interactive sessions were very enlightening.I would surely like to attend the May clinical trial conference. I congratulate Virtue Insight for organizing a very useful and interesting Conference." - Medical Department, Elder Pharmaceuticals
“PV 2010 was an opportunity to identify future clients as well as competitors along with an excellent learning platform” - Pharmaceutical Professional, Ecronacunova