IFPMA
Encyclopedia : I : IF : IFP : IFPMA
The IFPMA is the International Federation of Pharmaceutical Manufacturers Associations.
According to Medical News Today: "The International Federation of Pharmaceutical Manufacturers & Associations is the global non-profit NGO representing research-based pharmaceutical, biotech and vaccine companies and national industry associations in developed and developing countries. The industry's R&D pipeline contains hundreds of new medicines and vaccines being developed to address global disease threats, including cancer, heart disease, HIV/AIDS and malaria. The IFPMA Clinical Trials Portal and the IFPMA Health Partnerships Survey help make the industry's activities more transparent. The IFPMA strengthens patient safety by improving risk assessment of medicines and combating their counterfeiting. It also provides the secretariat for the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)." [Medical News Today] article WHO Commission Report On Biomedical Innovation, Patents And Public Health Contains Many Sound Proposals - But Underestimates Vital Role Of Patents published April 5, 2006
H5N1
The H5N1 pandemic threat has caused a vast increase in funding to influenza research."The IFPMA's research-based vaccine manufacturing members are conducting a growing number of clinical trials of 'prototoype' influenza vaccines, designed to counter to the threats of avian and pandemic influenza. [...] A total of 31 avian/pandemic prototype vaccine clinical trials are now listed by IFPMA, compared to 28 in January 2006. These vaccine trials involve 15 manufacturers, located in Australia, Austria, Canada, France, Germany, Italy, Japan, the Netherlands, Switzerland, UK and USA. sanofi pasteur alone has no less than eight different vaccine trials either recently completed or underway. A total of eleven Phase II clinical trials of prototype vaccines are either on-going or planned for 2006. Three prototype vaccines, one from Chiron / Novartis and two from GSK, have already been submitted as 'Mock Up' dossiers for approval by the EU regulatory authority (EMEA). The majority of projects target specific strains of influenza virus (H2N2, H5N1, wild type H5N1, H5N3, H7N1, H7N7, H9N2), but Merck focuses on development of a universal influenza vaccine, using an M-2 peptide conjugate protein. Among the influenza strain-targeted projects, 26 use an inactivated virus (10 whole virus, 10 split virus, 6 surface antigen), and 4 use a live attenuated virus. Almost all prototype vaccines use a traditional injection delivery system, although MedImmune uses a nasal spray. Sixteen projects use Aluminum salt as an adjuvant. Berna/Crucell uses a virosome carrier/adjuvant system; CSL, Aluminum phosphate; Chiron/Novartis, MF59 and GSK, a novel adjuvant system. Twenty-five projects use the traditional egg culture technology currently used to manufacture seasonal influenza vaccines, while 6 use cell culture systems." [Medical News Today] article There Are Thirty-One Avian & Pandemic Prototype Vaccines published May 2, 2006.
MedDRA
MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry throughout the entire regulatory process, from pre-marketing to post-marketing activities, and for data entry, retrieval, evaluation, and presentation. In addition, it is the adverse event classification dictionary endorsed by the ICH (International Conference on Harmonization). MedDRA is used in the US, European Union, and Japan. Its use is currently mandated in Europe and Japan for safety reporting.MedDRA is managed by the MSSO (Maintenance and Support Services Organization), an organization that reports to the IFPMA (International Federation of Pharmaceutical Manufacturers and Associations; www.meddramsso.com). MedDRA is free for regulators and priced according to company revenue for industry.
MedDRA version is released twice a year (March and September). Currently version 9.0 is slated for March 2006 release. MedDRA is updated continuously by subscriber change requests to add a new medical concept that is yet to be in MedDRA etc. The decisions are made by international medical officers on how to map the terminology within the grouping categories according to a general consensus based on language considerations internationally. The Japanese counterpart for MSSO is called JMO.
The FDA has committed to keeping current on MedDRA, and it has become the standard for adverse event reporting in the USA.
The MedDRA dictionary is organized by System Organ Class (SOC), divided into High-Level Group Terms (HLGT), High-Level Terms (HLT), Preferred Terms (PT) and finally into Lower-Level Terms (LLT). The Current MedDRA version is 9.0 (March 2006).
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