HYDERABAD: The Nizam’s Institute of Medical Sciences (Dept. of Clinical Pharmacology & Therapeutics), Hyderabad in association with MakroCare, a global clinical services firm, successfully organised the workshop on Pharmacovigilance, first of its kind in Hyderabad on November 14, 2008 to impart basic and fundamental knowledge and information on pharmacovigilance practices. The focus of the workshop was an overview on Pharmacovigilance, Adverse Drug Reactions (ADR), Post Marketing Surveillance (PMS) and Statistical Methods in PV and Signal Detection.
Mr. M. Venkata Reddy, Director, Natco Institute of Pharmaceutical Training & Research, Advisor, Natco Pharma Limited, Hyderabad, Member, Pharmacy Council of India, New Delhi, Former Director, Drugs Control Administration, Govt. of AP. Inaugurated the workshop by lighting the Lamps.
Speaking on the occasion, Mr. Reddy said that the DCGI is contemplating new and rigid rules to protect Indian consumers from spurious and hazardous drugs and those medicines whose safety profile is questionable. He spoke at length on the Indian Pharmacovigilance Program and encouraged Medical professionals to be actively involved in reporting adverse drug events. He requested Dr Naidu on behalf of the participants to start an adverse event-reporting center at NIMS.
Prof. M.U.R. Naidu Dean & HOD, Dept of Clinical Pharmacology & Therapeutics, Nizam’s Institute of Medical Sciences, Hyderabad introduced the Guest and delivered the welcome address. He highlighted the importance of pharmacovigilance and stressed upon the young professionals that the need of the hour is to have a dynamic and robust pharmacovigilance system.
Mr. Mahesh Malneedi, President, MakroCare was Guest of Honour on the occasion. Mr. Mahesh introduced MakroCare and explained about the opening up of Indian markets for clinical research. He highlighted the services that Indian companies can offer in terms of monitoring of drug safety. He said Indian companies have to brace and be prepared to have pharmacovigilance system to monitor the safety of their drugs, which they manufacture and then market.
Dr. Shobha Jagdish Chandra, Addl. Professor, Clinical Pharmacology & Therapeutics, Nizam’s Institute of Medical Sciences, Hyderabad welcomed the delegates and compare the program. Dr. Khalid Saifuddin, Senior Manager, Pharmacoviilance proposed vote of thanks.
Delegates from Pharma companies, CROs, academic institutions and hospitals attended and availed the great networking opportunity during Hi Tea and Buffet Lunch. More than 100 physicians, academicians, professionals and students community from pharmacovigilance field participated as delegates in the workshop.
A day – long workshop guided by expert speakers – Dr. M.U.R.Naidu, Dr. Shobha Jagdish Chandra, Dr. Grace Maria Anthony and Dr. Khalid Saifuddin helped the participants to understand and apply the process of pharmacovigilance and signal detection, reporting, treating, and also preventing ADRs to occur, to the extent possible. Apart from identifying and applying best practices of pharmacovigilance for company processes and procedures, it also helps to ensure quality in both post marketing pharmacovigilance and clinical safety. Photo Gallery
MakroCare,a global clinical services firm, provides clinical research support to pharmaceutical, biotechnology, and medical device industries. The company offers site selection, patient recruitment, project and data management, clinical monitoring, quality assurance, medical writing, PMS/PharmacoVigilance, biometrics, and regulatory assistance. MakroCare has offices in USA (New Jersey, Illinois, Pennsylvania), Asia (India) and Europe (Frankfurt).