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