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As per available reports about 65 Conferences, 381 workshops are presently dedicated exclusively to Pharma regulatory guidelinesand about 217 articles are being published on Pharma regulatory guidelines.
A Pharma regulatory guideline plays a critical function in the pharmaceutical industry and is concerned in all stages of drug improvement and also after drug authorization and promotion. The drug development progression is a extensive, composite and enormously expensive although essential process. Pharmaceutical companies use all the information accumulated through discovery and development stages in order to record the drug and thus promote the drug. All through the expansion stages, pharmaceutical companies have to stand for by an arrangement of stringent rules and guiding rule in order to make sure safety and efficacy of the drug in humans.
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Scope and Importance:
The Regulatory Affairs department is an important part of the organisational structure of pharmaceutical companies. Internally it liaises at the interphase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities.Regulatory Affairs is involved in the development of new medicinal products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities. Regulatory Affairs is actively involved in every stage of development of a new medicine and in the post-marketing activities with authorised medicinal products
To meet all challenges pharmaceutical companies need on the one hand additional resources to cope with peak workload. On the other hand they need expert knowledge and local experience to face the demands of new regulatory environments and requirements. The companies can either ramp up their regulatory departments or complement their internal resources by outsourcing of specific tasks.
There is an increasing trend towards outsourcing, which leads to cost-effective and lean processes. Having additional resources at hand for a certain period of time and sourcing specific expertise and local knowledge when needed keeps the regulatory departments agile and flexible. What is important to such an outsourcing strategy is the selection of the right partner at the right time. Selection criteria for outsourcing partners very much depend on the nature of the tasks to be transferred but also on the structure and organization of the pharmaceutical company concerned.
There is a great variety of regulatory consulting companies: Large firms acting globally with local presence in different countries, small firms specializing in one or the other area of regulatory affairs or specific regions. Identifying the right partner at the right time is vital to successful outsourcing
Analyses of global market trends, with data from 2012-2014, and projections of CAGRs through 2019.A look at the current state of the drug discovery market, existing platforms and products on the market, and detailed analysis of the competitive environments including new, potential venues for novel technologies and approaches. Descriptions of various products such as bioanalytical instruments, high-throughput screening devices, informatics, and microarrays.Analyses of the main positive and negative factors in each sector of the market, potential future trends, and emerging technologies accross different segments of the industry. The global market for regulatory affairs reached nearly $39.5 billion and $46.5 billion in 2013 and 2014, respectively. This market is expected to grow at a compound annual growth rate (CAGR) of 11.3% to nearly $79.5 billion for the period 2014-2019.
International symposium and workshops
1. 4th African Regulatory Conference, 27 - 28 April 2015, Dakar, Senegal.
2. 8th Asia Regulatory Conference Advancing Best Practices for Regulatory Review and Submission in Asia, 4-5 February 2015, Taipei, Chinese Taipei
Relevant Society and Associations
This page will be updated regularly.
This page was last updated on 11th Sep, 2015
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