Pharmexcil's 2nd Patent Facilitation Centre to be set up at NIPER, Mohali

The Pharmaceuticals Export Promotion Council will launch its second Patent Facilitation Centre (PFC) at National Institute of Pharmaceutical Education and Research (NIPER), Mohali, by the end of the month to provide patent related information for the exporters in Northern Region.Pharmexcil, which had launched its first PFC at Hyderabad in July, 2008, will launch the second centre on November 26, 2009. The centre will also provide a platform to students at NIPER to engage in patent related services to pharmaceuticals industry through various projects and research activities.

The council has altered its earlier plans to set up a centre at New Delhi to support the exporters in Northern Region and has finalised the location at Mohali considering the suggestion of the Department of Pharmaceuticals. Launching of PFC at Mohali will also help the exporters around the area, with pharma manufacturing hubs like Himachal Pradesh, Uttranchal are at proximity, said Dr P V Appaji, executive director, Pharmexcil.

"There are a lot of resources and data available at NIPER, Mohali. Further, the location is also near to so many pharma manufacturing hubs including Baddi. For the timebeing, our centre at Mohali will act as the support centre for pharma exporters in Northern Region," informs Dr Appaji.

The centre is being set up with funding support from Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers. Pharmexcil is hiring the small facility at NIPER, Mohali.

NIPER director Dr Rama Rao resigns

Amid allegations about his extension of services by the department of pharmaceuticals (DoP), the director of the National Institute of Pharmaceutical Education and Research (NIPER), Mohali, Dr Rama Rao has resigned on November 16. Dr Rao was on extension till December 31 this year.

According to sources, the board of governors of the premier institute, which met on November 17, has recommended to the government to accept his resignation. Dr Rao's five-year term as the director of the institute had ended on August 31 this year and he has been given four months extension by the DoP till the appointment of the new director.

Medifest 2009 to be held in New Delhi

DELHI IS all set to host the fourth edition of one of the biggest medical and healthcare technology trade events in India– ‘Medifest 2009’ from December 11 to 13, 2009, at Pragati Maidan. It would be a grand show delivering diverse assemblages of elites playing a major role in creating awareness in the society and educating people about the latest advancements in the healthcare sector.

“The main objective behind Medifest, is to bring together all those related with the medical and healthcare sector under one roof and provide to the health, wellness and pharma sector, the opportunity to pick and choose from the best of the technology and products world over. The event will facilitate transaction of significant volume of exports and domestic orders and will take India to new heights in the field of medical world” said Roohit Madan, chief executive officer, Vantage Trade Fairs (P) Ltd, the organisers of Medifest, 2009. Further he adds an expansion drive worth Rs 6,000 crore in NCR area only has already been initiated by leading corporate hospitals and major player like Fortis Healthcare Ltd, Moolchand Medicity, Medicity Gurgaon etc.

Medifest 2009 would be visited by a gamut of members from the medical and paramedical fraternity including doctors, scientists, paramedics, hospitals, manufacturing and pharmaceutical houses, R&D organisations, government agencies, medical institutes, importers, distributors, retailers etc.

NuvaRing launched in India

With the introduction of a product that will augment the contraception options currently available to Indian women, NuvaRing, the first vaginal birth control ring was formally launched in India. NuvaRing is a once-monthly vaginal ring that offers the same benefits as ‘the Pill’ but with the added convenience of not having to be used daily.

NuvaRing is a flexible, transparent ring containing hormones that are dispersed throughout the ring’s core and absorbed through the vaginal lining directly into the bloodstream, when inserted. The exact positioning of the ring is not critical for it to work. Additionally, the ring works, like ‘the Pill’, by inhibiting ovulation. In order to prevent pregnancy for a full month, NuvaRing must be inserted and left in place for three consecutive weeks. After a one week ring-free interval, a new ring must then be inserted in order to have continued contraceptive effect.

FDA Approves Additional Vaccine for 2009 H1N1 Influenza Virus

The U.S. Food and Drug Administration announced that it has approved a fifth vaccine for protection against the 2009 H1N1 influenza virus. The vaccine is manufactured by ID Biomedical Corp. of Quebec, Canada, owned by GlaxoSmithKline PLC.

As with the four previous H1N1 influenza vaccines licensed by the FDA on Sept.15, 2009, ID Biomedical Corporation will manufacture its H1N1 vaccine using the established, licensed egg-based manufacturing process used for producing seasonal flu vaccine.

Potential side effects of this H1N1 vaccine are expected to be similar to those of the seasonal and H1N1 flu vaccines. The most common side effect is soreness at the injection site. Others may include mild fever, body aches and fatigue for a few days after the inoculation.

As with any medical product, unexpected or rare serious adverse events may occur. The FDA is collaborating with other government agencies to enhance adverse event safety monitoring during and after the H1N1 2009 vaccination program.

ID Biomedical’s H1N1 monovalent vaccine will be produced in multi-dose vials, in a formulation that contains thimerosal.

As with any medical product, unexpected or rare serious adverse events may occur. FDA is collaborating with the U.S. Department of Health and Human Services, including the Centers for Disease Control and Prevention, and other government agencies to enhance the capacity for adverse event safety monitoring during and after the 2009 H1N1 vaccination program.

For more information FDA Page on Influenza A (H1N1) 2009 Monovalent Vaccine

Advanced GCP workshop - 30 Nov 2009, Hyderabad

Workshop on GCP 2010: FAQs Exploring common GCP Myths and misconceptions
30 November 2009
At Hotel Green Park, Hyderabad
By
Arkus Clinical Trial Support Solutions, Ahmedabad & PharMantra Consulting Services, Hyderabad

Trainers - Dr. Anupama Ramkumar M.D
Ranjani Nellore, Ph.D., RAC

Cost of the program: Rs. 4500/-per participant
(Inclusive of course material, lunch and refreshments)

Who would benefit – This highly interactive workshop is an essential GCP refresher and problem solver for all clinical research professionals striving for GCP compliance amidst multiple priorities. Understand where we commonly misinterpret GCP requirements and add more chaos to the already existing dichotomies. Learn to separate the facts and true expectations of GCP compliance in clinical research in order to become more effective. An absolute must attend for all clinical research professionals in sponsor, CRO, SMO companies, principal investigators and site staff.

About the trainers:
Dr Anupama Ramkumar, M.D (Med) is a well known GCP Trainer in India and runs Arkus Clinical Trial Support Solutions, a rapidly growing, training and consulting firm engaged in assisting sponsor companies running their trials in India, helping identify/audit CROs/sites and other vendors for optimal trial conduct and logistics. She has been a part of the clinical research Industry in India since its early days and has herself been an Investigator on Phase 1 trials while working as the Medical Director at Lambda Therapeutic Research, Ahmedabad,India.

Ranjani Nellore, Ph.D. RAC is a regulatory affairs certified professional with over 12 years of pharmaceutical industry experience in USA and India. She has submitted clinical trial applications and INDs to FDA, MHRA, TPD (Canada) and DCGI for several NCEs. She has participated in meetings with the EMEA and US FDA. She is an invited speaker at national and international meetings and renders customized training programs. She has now established PharMantra Consulting Services which provides regulatory consulting services to the global health science industry.

To register, please send email to:
anupama.ramkumar@ gmail.com; ranjani@pharmantra. com or
Call - Dr Anupama at 98254 13761 or Dr. Ranjani at 99590 72225