Different aspects of pharmacovigilance discussed and debated at the conference by thoughtleaders and experts
Usha Sharma – Mumbai
DIA India recently organised a two-day conference on ‘Innovations in Pharmacovigilance – the era of e-PV’ in Mumbai. During the conference, speakers touched upon different aspects of pharmacovigilance, including the importance of European Union electronic application forms and procedures of submission.
Stewart Geary, Chief Medical Officer, Vice President and General Manager, Eisai, delivered the keynote speech on the role of post – marketing safety studies in pharmacovigilace in the era of ePV.
Other speakers at the event were Stewart Geary, Chief Medical Officer, Vice President and General Manager Eisai; Dr Seema Jaitly- Managing Director, Essjay Solutions; Sameer Thapar, Global PV Operations and Quality Assurance, Oracle, Jose Alberto Ayala Ortiz, Chief Executive Officer, Pharmacovigilance Consultant, Pvpharm; YK Gupta, Head Department of Pharmacology, AIIMS; Moin Don, CEO and President, PVCON; Suneela Thatte, Vice President Global Operations, Quintiles; Renuka Munshi, Associate Professor and Head Department of Pharmacology, TN Medical College and BYL Nair Hospital; Swapnil Raut, Director Compliance and Oversight, Pfizer; V Kalaiselvan, Principal Scientific Officer, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India; Sibin Kurian, Head DS&E, Clinical Scientific Director, Novartis Pharmaceuticals; Christine G Lim, Head Regional Medical Safety (APAC, EMEA and LATAM) Medical Devices and J&J; Milind Sardesai, GM, Medical Safety Services, Cognizant; Pooja Jadhav, Drug Safety Physician, Sun Pharma, Sanyogita Rane, Senior Lead Safety Physician, Sciformix; Gunjan Shah, Delivery Manager, Sciformix; David Balderson, Global Vice President Safety Operations, Sciformix; Rajesh Jain, Director Operations, Cognizant; Jayathirtha Gopalakrishna, Principal Sales Consultant, Oracle; Balaji Shantharam & Padmanabhan GM, Compliance Lead, ArisGlobal; Shravanti Bhowmik, Associate Vice President, Clinical Research, Sun Pharma; Sanjay T Gandhi, Vice President Public Health, GSK; Sayed Ziaur Rahman, Associate Prof – Dept of Clinical Pharmacology, Aligarh Muslim University; Sachin Kuchya, Associate Professor in Pharmacology, NSCB Medical College; Dr Jamal Baig, Country Head, Pharmacovigilance, Merck Sharp and Dohme; Dr J Vijay Venkatraman, Managing Director and Chief Executive Officer, Oviya Medsafe; Shefali Gupta, Head of Strategic Initiatives, LS – BPS TCS; Sumanta Ghosh, VP Operations, PV Capability Lead, Accenture; Vineet Shastri, Sr Director and Head, Life Style Medical Services, Global Delivery Network, Quintiles; Manish Paralikar, Process Excellence Lead, Life Sciences BPS, Cognizant and Sanjeev Miglani- Head PV US Operations, APCER Life Sciences.
Jaitly spoke on EU’s electronic application forms. She also briefed how marketing authorisation holders should register all non-international Post-Authorisation Safety Studies (PASS). She also highlighted how the new EU legislation helps in maintaining consistency, reducing complexity, sharing of information and avoiding duplication.
Thapar talked about the benefits of going the automation route in signalling while Ortiz talked on understanding Eudravigilance and XEVMPD.
The first day saw a panel discussion which addressed the issues faced by the Indian clinical trials industry. The panelists, also highlighted the steps being implemented by the industry to regain the growth momentum. They also discussed the significant regulatory changes implemented in the Indian clinical trials industry in the last three years and their impact.
Don was the moderator of the session. YK Gupta provided detailed information of the Indian clinical research industry and put forth his views on why India should conduct more clinical trials. He also spoke on the need and relevance of the compensation guidelines for clinical trials in India.
Answering Don’s query on whether media has contributed to the negative image about the Indian clinicial trials industry, Raut opined that the media needs to be more balanced in its reporting. She also pointed out that not a single CRO in India has received warning letters from US FDA.
However, Gupta offered a counterview and said that the Indian clinical trials industry and institutional researchers should proactively engage with the media and talk about their efforts to ensure a balanced coverage of the issues by the media.
Moin pointed out that in 2010, there were over 500 plus ongoing trials in the country but by 2013, there were only 100 plus trials being conducted. He asked Thatte about the steps needed to bring back clinical trials to India’s shores. She spoke on the reasons that caused the exodus of clinical trials from the country but also emphasised that there was a need to implement better regulations to ensure that patients do not suffer. She opined that the measures introduced in the last three years has helped in creating a more robust regulatory system for clinical trials. She gave examples of the rise in adverse drug reporting (ADR) and better compensation guidelines to prove her point.
Munshi spoke on the clause which requires AV recording of patients’ consent before beginning the clinical trials and the challenges in doing so.
Thus, the two-day conference brought together many thought leaders and stakeholders of the pharma industry to deliberate on current best practices, novel initiatives to augment handling of drug safety data and other pivotal areas in ensuring pharmacovigilance in India.