14th Pharmacovigilance 2017
Offering our customers the knowledge and connections for a profitable business
Speakers
  • R. CHANDRASHEKAR

    R. CHANDRASHEKAR CDSCO West Zone Mumbai

  • R. K. SANGHAVI

    R. K. SANGHAVI Indian Drug Manufacturers' Association (IDMA)

  • VIJAY SINGHVI

    VIJAY SINGHVI Food and Drugs Administration

  • DEEPA ARORA

    DEEPA ARORA Lupin

  • MANISH VERMA

    MANISH VERMA Sanofi

  • SARABJEET KAUR

    SARABJEET KAUR APCER Life Sciences

  • AMBRISH SRIVASTAVA

    AMBRISH SRIVASTAVA Alkem Laboratories

  • VIKRAM GOTA

    VIKRAM GOTA ACTREC, Tata Memorial Centre

  • BHASWAT CHAKRABORTY

    BHASWAT CHAKRABORTY Cadila

  • RAHUL GUPTA

    RAHUL GUPTA USV

  • UJWALA NAIK

    UJWALA NAIK Johnson & Johnson

  • JAMAL BAIG

    JAMAL BAIG Merck Sharp & Dohme

  • PRAVIN GHADGE

    PRAVIN GHADGE Reliance Life Sciences

  • SUJAY SURESH KULKARNI

    SUJAY SURESH KULKARNI GSK

  • ANAY SHUKLA

    ANAY SHUKLA Nishith Desai Associates

  • GURPREET SINGH

    GURPREET SINGH Novartis

  • GAURI UTTURKAR

    GAURI UTTURKAR Glenmark Pharmaceuticals

  • NIDHI VAISH DAS

    NIDHI VAISH DAS Roche Pharmaceuticals

  • MANOJ SWAMINATHAN

    MANOJ SWAMINATHAN Piramal

  • ABHAY CHIMANKAR

    ABHAY CHIMANKAR Rhyme Life Sciences

  • SANKET SAWANT

    SANKET SAWANT SIRO Clinpharm

  • PRANJAL BORDOLOI

    PRANJAL BORDOLOI Veeda Clinical Research

  • RAJASHRI SURVASE OJHA

    RAJASHRI SURVASE OJHA Raaj GPRAC and Raaj Pharma eLearning

  • RAJANI ROKADE

    RAJANI ROKADE PharmaSoulz

  • PRASHANT  BODHE

    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”

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CONFERENCE INTRODUCTION:-

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
  • Consultants

 

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.

09:30 – Chairperson opening remarks
RAJASHRI SURVASE OJHA, Founder and MD, Raaj GPRAC and Raaj Pharma eLearning


MARKET OVERVIEW & ANALYSIS

09:40 – Pharmacovigilance In & Out
VIJAY SINGHVI, Technical Officer, Food and Drugs Administration


10:10 – 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


10:40 – Morning Coffee/Tea & Discussion

CHALLENGES & OPPORTUNITIES


11:00 – 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

Moderator:
PRANJAL BORDOLOI, AVP - Medical Affairs and Pharmacovigilance, Veeda Clinical Research

Panellists:
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
R. K. SANGHAVI, Sr. Consulting Clinician & Chairman - Medical Committee, Indian Drug Manufacturers' Association (IDMA)


ADDING VALUE TO THE GLOBAL PHARMA INDUSTRY

11:50 – 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

Moderator:
PRASHANT BODHE, Director, CliniSearch

Panellists:
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


12:30 - Networking luncheon

Afternoon Chair Person
PRASHANT BODHE, Director, CliniSearch


13:30 – An Interactive session on the Final Guidance document of Pharmacovigilance for Marketing Authorization Holders- Industry Perspective” released by PvPI on 29 Sep 2017
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

Moderator:
RAJANI ROKADE, Founder-Director, PharmaSoulz

Panellists:
VIKRAM GOTA, Associate Professor, ACTREC, Tata Memorial Centre
GURPREET SINGH, Head of Vendor Management in PV, Novartis
SANKET SAWANT, Strategy & Business Development Partner, SIRO Clinpharm
ABHAY CHIMANKAR, Founder and Director, Rhyme Life Sciences
UJWALA NAIK, Country Head-Pharmacovigilance, Johnson & Johnson


15:00 – Empowering PV Culture amongst Clinicians
R. K. SANGHAVI, Sr. Consulting Clinician & Chairman - Medical Committee, Indian Drug Manufacturers' Association (IDMA)

15:30 – Afternoon Tea/Coffee


15:50 – 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

REGULATORY


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

Moderator:
ANAY SHUKLA, Associate, Nishith Desai Associates

Panellists:
AMBRISH SRIVASTAVA, Vice President: Medial Affairs, Clinical Research & Regulatory, Alkem Laboratories
R. CHANDRASHEKAR, Dy. Drugs Controller (India), CDSCO West Zone Mumbai
RAHUL GUPTA, Vice President, Regulatory Affairs, USV
GAURI UTTURKAR, Drug Safety Physician, Glenmark Pharmaceuticals


17:00 – Chairperson’s closing remarks and end of conference


17:10 – 18:00 – Networking Drinks Session

R. CHANDRASHEKAR

Dy. Drugs Controller (India)

CDSCO West Zone Mumbai

Mr. Chandrashekar Ranga has an Honors degree in Pharmacy and Masters in Pharmaceutical Technology. He has also Degree in law and PG Diploma in Intellectual Property Laws.

He has 27 years experience in Drug Control Departments of the State and Central Governments in various capacities and is currently working as Deputy Drugs Controller (India) at CDSCO West Zone, CDSCO, Ministry of Health and Family Welfare, Govt. of India.

He has earlier headed the new drugs division including the IND drugs,  International Cell, Legal Cell and the E-Governance Cell at CDSCO. He played a key role in the signing of the Memorandum of Understanding with various countries including US FDA, UK-MHRA, Japan-PMDA, ANVISA, Brazil and the BRICS group.

He has played a key role in drafting amendments to the Drugs and Cosmetics Act, Drugs and Cosmetics Rules and Medical Devices Rules. He also dealt with the litigations filed at various courts on behalf of CDSCO. He was appointed on various committees constituted to revise the existing drug regulations.

He has initiated the e-Governance program at CDSCO. His intense efforts led to launch of SUGAM portal, the online initiative for CDSCO for filing, tracking and processing of various applications. Major services of CDSCO are now online.

Earlier he was heading the generic drugs approval division and the BA/BE division.

R. K. SANGHAVI

Sr. Consulting Clinician & Chairman - Medical Committee

Indian Drug Manufacturers' Association (IDMA)

Achievements

•    Consulted over 80 small-, medium- & large-sized Pharma & Nutra Companies (including MNCs) in areas of new pharma & nutra products, product launches (including OTC), positing of products, including re-positioning successfully established brands.
•    Pioneered the nutraceutical segment in India.
•    Given lectures on nutra (mainly) and pharma products to across all Dr Specialties in all major metros and most Tier-I & Tier-II cities, including overseas – Africa, Asia & Middle East.

Skills & Abilities

MANAGEMENT

•    Chairman – Medical Committee (13 years) & Chairman – Nutraceutical Committee (6 years) of Indian Drug Manufacturers’ Association (IDMA) – the largest Pharma body.
•    Nominated by ALL Pharma Industry associations jointly to deliberate with regards to establishing the rationality of 294 Fixed Dose Combinations (FDCs) deemed as not rational with the Drug Technical Advisory Board (DTAB) appointed subcommittee.
•    Nominated by IDMA as representative on panel for National Formulary of India (NFI).
•    Conferences: Organized: 20; Participated: 18

SALES

•    Product-related lectures have positively influenced sales of primarily nutra products & also pharma products.
•    The initial launches of all nutra products undertaken resulted in each brand clocking minimum of over 5 crores INR.

COMMUNICATION

•    Successfully convinced Drs with regards to benefits of various products’ merits via various talks given.
•    Acknowledged as a knowledgeable trainer with ability to simplify and ensure assimilation of
information by most field force over the last 3 decades.

LEADERSHIP

•    Successfully led the Healthcare Sector with a dedicated team in 5 consecutive legal cases (including Supreme Court) with matters pertaining to regulatory issues hindering industry’s growth unjustifiably.

VIJAY SINGHVI

Technical Officer

Food and Drugs Administration

Name -Vijay S. Singhavi
Qualification – M.Pharm, L.L.B.
Post - Technical Officer (Allo.),
Organisation _ Food & Drugs Administration, Maharashtra State. Mumbai 51
Contact no - 9892832814,
Mail - vijaysinghavi@yahoo.co.in
         techallod14@gmail.com

Recipient of Gold Medal from Nagpur University for 1st Merit in B. Pharm Exam 1989
Started carrier as Lecturer in Pharmaceutics at Institute of Pharmacy Pusad , Yeotmal District, M.S.

Join FDA M.S. in 1993 as a Drugs Inspector. (More than 22 Years as a Drugs Inspector)

Promoted as Technical Officer (Allo.) on 3rd May 2016 in FDA (more than 1 Year as a T.O.)

DEEPA ARORA

Vice President - Pharmacovigilance & Global Head - Drug Safety & Risk Management

Lupin

MANISH VERMA

Director and Head of Medical Affairs, South Asia Zone

Sanofi

Dr Manish Verma is an Internal Medicine specialist, a clinical practitioner turned pharmaceutical physician with more than a decade of experience in new drug development, patient support programs, public health initiatives and clinical research in the field of non-communicable disease mainly, diabetes, hypertension, dyslipidemia and cardiovascular diseases. Currently he is working as Director Medical Affairs at Sanofi India limited. Has published several papers in journal of high repute and presented at various national and international conferences. Has moderated several multi-stakeholder meetings and also served as scientific committee member for the countries first ever white paper for strengthening policies on diabetes care.

SARABJEET KAUR

Associate Vice President- Pharmacovigilance

APCER Life Sciences

Sarabjeet Kaur is a trained pharmacist and has over 12 years of experience in handling drug safety and pharmacovigilance requirements across the globe (US, EU, Australia and Asia Pacific) for generic as well as innovator business. In her current and prior experience, she has successfully lead development and implementation of projects in pharmacovigilance, quality and training areas focusing on service delivery for case management, aggregate reports, safety database upgrades, legacy data migrations both in post marketing and clinical safety. In her current role at APCER she heads the pharmacovigilance operations in case management, literature screening and PSMF delivery verticals for small, mid and large-scale sponsors with global PV landscape.

AMBRISH SRIVASTAVA

Vice President: Medial Affairs,Clinical Research & Regulatory

Alkem Laboratories

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.

VIKRAM GOTA

Associate Professor

ACTREC, Tata Memorial Centre

After my MD in pharmacology from Christian Medical College, Vellore, I joined Lotus Labs Pvt. Ltd., Bangalore in 2005 as a clinical investigator for Bioequivalence studies. In February 2006 I joined Tata Memorial Hospital as a clinical research coordinator in the INDO-Oxford (INDOX) Cancer Trials Network where I was trained in the design and conduct of phase I clinical trials. During this time I also obtained the post graduate diploma in clinical trials from the London School of Hygiene and Tropical Medicine, University of London. I started the department of clinical pharmacology at ACTREC, Tata Memorial Centre, in July 2008. My research interests include early clinical development and pharmacokinetics driven optimization of drugs. I have worked as a clinical investigator in several first in human trials in oncology. My lab also undertakes studies that explore exposure-effect relationships for efficacy and toxicity which enable us to develop strategies for therapeutic monitoring of drugs used in cancer.

BHASWAT CHAKRABORTY

Senior VP & Chair, Research and Development Core Committee

Cadila

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

RAHUL GUPTA

Vice President, Regulatory Affairs

USV

UJWALA NAIK

Country Head-Pharmacovigilance

Johnson & Johnson

JAMAL BAIG

Country Head- Pharmacovigilance

Merck Sharp & Dohme

Area of Interest: Drug Safety and Pharmacovigilance, Regulatory Affairs, Cardiovascular Pharmacology.

Experience:

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.

PRAVIN GHADGE

Head - Medical Writing & Pharmacovigilance

Reliance Life Sciences

SUJAY SURESH KULKARNI

Senior Manager, Medical and Regulatory Affairs

GSK

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

ANAY SHUKLA

Associate

Nishith Desai Associates

GURPREET SINGH

Head of Vendor Management in PV

Novartis

“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.”

GAURI UTTURKAR

Drug Safety Physician

Glenmark Pharmaceuticals

I am Dr Gauri Utturkar, MBBS and Diploma in Drug regulatory and Intellectual property by qualification. I have approximately 7.5 years of work experience in Pharmacovigilance as well as pharma industry. I am working with Glenmark Global PV team for last more than 2 years in the role of Manager for Global PV team.

My key responsibilities include managing responsibilities related to product safety for marketed and developmental products. I am also responsible for authoring aggregate reports as PSURs, PBRERs and PADERs; risk management plans, signal management activities and performing clinical trial activities globally in Glenmark.

NIDHI VAISH DAS

Drug Safety

Roche Pharmaceuticals

Pharmacy graduate

Head the PV department at Roche pharmaceuticals India Responsible for hub countries ( Srilanka, Nepal, Bhutan) Has a total of 13 yrs of experience in pharma industry of which 5 yrs is core pharmacovigilance

Faced Several Roche PDQ (product quality assurance)audits with no critical finding Worked in sales and medical information prior to joining the pharmacovigilance team

MANOJ SWAMINATHAN

Chief Manager / Head - Global Pharmacovigilance

Piramal

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.

ABHAY CHIMANKAR

Founder and Director

Rhyme Life Sciences

Physician by profession and a global leader with expertise and experience more than 15 years in drug safety and pharmacovigilance regulatory affairs with additional experience in medical writing, clinical trials, BA/BE monitoring, and auditing.  Well-versed in global regulatory guidelines and speaker at national and international conferences.  Strong manager known as a keen planner, strategist, and implementer with solid track record of results that deliver business value through streamlined PV operations.

Audited many pharma companies as third party auditor. Extensive experience in USFDA and MHRA inspections, and acting as a consultant for regulatory inspections with a good inspection outcome.  One of the leading PV expert(consultant) in India. Vision is to make Indian companies prepared for inspection with no or minimal findings.

SANKET SAWANT

Strategy & Business Development Partner

SIRO Clinpharm

Dr. Sanket Sawant is a medical graduate with masters in management studies from K.J. Somaiya (specialization in marketing). An overall experience of over 9 years including experience of marketing and selling varied services across the entire portfolio of the drug development cycle including clinical trial operations, data management, medical writing, biostatistics, pharmacovigilance, licensing and regulatory consulting across phase I-IV trials, PMS, medical device trials. Started his career in the clinical research industry as a medical writer and grew up the ladder to be a full time business development professional.  Currently, he is associated with SIRO Clinpharm as Strategy and business development partner and in the past have worked with companies like Sciformix and TCS. A diverse background spanning across service delivery, project management, and business-development disciplines underscores my expertise in engaging decision makers and formulating winning pre-sales and sales strategies and solutions.

PRANJAL BORDOLOI

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.

RAJASHRI SURVASE OJHA

Founder and MD

Raaj GPRAC and Raaj Pharma eLearning

Mrs. Rajashri Survase-Ojha is a senior RA professional, GMP consultant and Auditor and has over 26+ years of very versatile experience in pharmaceutical industry, starting her career FROM Scientist in R & D, Analytical & Formulation, QA-QM, till handling of GLOBAL regulatory Affairs. Expertise in getting marketing approvals of Generics, DRUG SUBSTANCE/DRUG PRODUCTS/MEDICAL DEVICES/OTC/Neutraceuticals & FOOD across the Globe.

Rajashri is the founder and Director in Raaj GPRAC [‘Raaj Global Pharma Regulatory Affairs Consultants] Thane-Mumbai since 2010 and completed 7.5 successful years of women Entrepreneurship. Raaj GPRAC is an ISO29990-2010 certified institute.

She was awarded for ‘’ Women's leadership India Awards in Pharma Coaching ‘ by iiGlobal in February2017.She brings with her more than 26+ years of rich experience working for leading organizations like SPECTRUM, Raaj GPRAC, COGNIZANT , FAMYCARE , NOVARTIS, GSK-TCS, GLENMARK, SANDOZ, Ciba-Geigy, UNICHEM Labs, and LOCAL FDA, Bandra.

She is RAPS qualified and also hold PG Diploma in Intellectual Property rights (IPR), Pharma Quality Management and is a Regulatory Submission expert of CTD/eCTD/ACTD/NeeS formats. She has TRAIN the TRAINER, Six Sigma Green belt, 7 habits of most effective people and Cornerstone leadership certifications.

She has published more than 15 Articles and Research papers in reputed journals.

She has Trained more than 7500 candidates till now on various aspects of GLOBAL Regulatory Affairs, GMP, GLP, GCP, GDP, Country-specific Regulatory Submissions(USFDA, EMA, ROW, ANVISA, WHO, ASEAN, SFDA, CDSCO-DCGI & Others), Quality Assurance & COMPLIANCE, 21CFR PARTS, GAMP-5, CSV, Clinical Research, Pharmacovigilance, Patents, Pharma Documentation and Pharma Management etc in Pharma & Biotech industry.

Hands on expertise in Regulatory Affairs(RA) and ‘Regulatory Intelligence’(RI) and setting up of new business processes and operations of ‘Regulatory Affairs’ and ‘Regulatory Information Management (RIM)’ and Training centers across the globe. Competent, diligent & result oriented professional experienced in Strategic Management, New Organizational Set-ups, Project Management, Resource Management, Compliance Management , Regulatory Submission Management across the globe.

Significant experience in Registration, Liasoning and marketing Approvals of pharmaceutical Drug substance and Drug Products. Handled submissions of IND/NDA/ANDA/ANDs to different National & International Health Authorities. Supported Regulatory Audits for USFDA, UK-MHRA, EdQM, ANVISA, TGA, SFDA, TFDA, MHLW, WHO and other local Health Authorities.

She is also associated with many leading education institutes/colleges in India as a ‘Guest faculty’.

RAJANI ROKADE

Founder-Director

PharmaSoulz

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
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Virtue Insight

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.

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Lex Witness

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.

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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.

 

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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.


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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.


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The conference programme consists of world-class keynote addresses, case study presentations and panel discussions.


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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 – delegate@virtueinsight.com


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Testimonials from our past Pharmacovigilance Conferences

 

 

Very nicely managed. Good Speakers & content. Cooperative and convenient venue. Nice management of time. Good opportunity for networking – Assistant Manager Pharmacovigilance, Mega Lifesciences

14th Pharmacovigilance Summit 2017 was an insightful and quite resourceful in the area of pharmacovigilance and the upcoming guidelines which is expected to come in force by 1st Jan 2018 AGM – Business Development, Clinical Trial Services

The Venue, key speakers included from big pharma companies & CROs has been perfect for the topic of panel discussion MSA, George Clinical

Very good conference to have knowledge about pharmacovigilance in briefly & also to understand the guidelines of India which is coming in 1st Jan 2018 Regulatory Affairs Executive, Ashish Lifesciences

The session was knowledge transfer/sharing and valuable too Associate Manager, IQVIA (formerly known QuintilesIMS)

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

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Conference pictures can be viewed and downloaded at our official Virtue Insight facebook page

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