HYDERABAD: Virtue Insight provides a platform to share knowledge and insights and networking opportunities to make new business alliances in the pharmaceutical industry. They had organized Pharmacovigilance 2010 – “Overseeing risks & Optimizing drug safety in today’s pharma market” at Hotel ITC Maratha, Mumbai on January 21-22, 2010.
The conference discussed about improving patient care and safety in relation to the use of medicines and other interventions and the on-going pressing concerns faced in drug safety, addressing the risks, timeline and budget constraints, whilst effectively tackling key challenges in overcoming trials agreement and site contract negotiation hurdles.
Mahesh Malneedi, Founder, Makrocare Clinical Research Ltd., shared his presentation on “Emerging Technologies and Strategies for Drug Safety Evaluation” at the conference. Mr. Mahesh was one among the stalwarts of the Pharma Industry including – Mr. Akhilesh Sharma, Vice President & Global Head Clinical Management & Global Pharmacovigilance, Dr. Reddy’s; Mr. Zoher Sihorwala, Vice President, Global Regulatory Affairs, Dr. Reddy’s; Mr. Manoj Sharma, Group Head – Pharmacovigilance, Panacea Biotec; Ms. Simrat Sohal, Head – Pharmacovigilance, Eli Lilly; Mr. Subbaraju Sagi, Sr. Solutions Consultant, Oracle Life Sciences; Mr. Sanish Davis, Clinical Research Manager, PGRD-Pfizer; Ms. Veena Ranjan, Head Patient Safety, AstraZeneca; Dr. Deven Parmar, Vice President – Clinical Research & Pharmacovigilance, Wockhardt; and Mr. Vishwas Sovani, MD VP, Pharma Delivery, Tata Consultancy Services, who have shared their knowledge on different subjects relating to Pharmacovigilance, and Drug Safety with the delegates of the Pharmacovigilance 2010.
Mr. Mahesh began his presentation in a unique way by displaying the word RISK in tricolors (Red, Orange and Green). He reiterated the fact that Risk management plan should be more fundamentals of how the company’s grouping and value proposition defines the solution and that is where the technology comes in to the picture. He opined that Risk management should drive the people’s process and technologies. He interacted on the following points:
Risk management is NOT equal to risk management plan! – He said that the Risk management plan should be more products focused and process focused. In addition he focused on the role of Information Science. Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time, high quality, cost reductions and increased efficiencies. He remarked IS has made my work easier and straightforward. He explained that the challenge itself is not a straightforward challenge. Systematically analyzing, interpreting data involving multiple drugs, medical conditions, and events per report.
He elucidated that the chronic under-reporting, occasional publicity driven and litigation driven episodes of over-reporting and misreporting, incomplete and missing information, and inconsistencies and changes over time in reporting and naming / coding practices are some of the hindrances.
Information Challenge: Mahesh also discussed about what exactly and how big is the Information challenge – the extraction of useful information from this database presents multiple challenges. He said that the company’s strategy depends upon what the company is about. In mid level companies, he opined, have not many opportunities of marketing in the regulated sector and at times they don’t know how to. He stressed that we cannot push our pharmacovigilance responsibility to somebody else. We have to one way own it.
The solution offered:
“Make things simple for your own self. And this is all what your pharmacovigilance system is supposed to do. If you don’t have a system and are looking at a system, all you should look at is: will it make my life easier?” is the solution, according to Mr. Mahesh.
Tools and Technologies needed:
Intake: call center, fax/ email chat
Process: safety systems
IT: Integrations to CDMS, CTMS
Analysis Improve: signal detection/ data mining
Align operational activities across different functional groups
Implement well defined decision-making models
Retain key pharmacovigilance personnel with cross-disciplinary expertise
Examine corporate IT platform and have vision for a long term
In conclusion, Mr. Mahesh replied to the queries of the delegates from Pharmaceutical and Biotechnological Companies, Contract Research Organisations, Clinical Research Scientists, Drug Regulators, Academia, Patient Recruitment Companies, healthcare organisations, and Non-profit Organisations/Association, and Consultants and thanked for the opportunity to share his views.