Regulatory Affairs Professionals

Pharmaceutical companies have recourse to aU the art of sophisticated advertising, promotion, public relations and specialist agencies, as well as having their own trained marketing professionals. Consequently written, documentary and published promotional items are usually reviewed and scrutinised by the company medical advisers for conformity with the known data and the ABPI Code of Practice, while the regulatory affairs professionals usually ensure conformity with the product licence. A pharmaceutical... 

Because of their importance in pharmaceutical analyses, much attention has been focused on harmonizing the parameters necessary for the validation of chromatographic methods. While some of these parameters are applicable to other analytical techniques, it is the responsibility of the analytical chemist to select and tailor the appropriate parameters and acceptance criteria for the particular method to be validated. Since most analytical chemists are not experts on regulatory matters, it is essential for the regulatory affairs professional to understand the requirements of method validation and work closely with the analytical chemist to select appropriate validation parameters and meaningful acceptance criteria. 

RAPS (Regulatory Affairs Professionals Society), 2005,2005 Fundamentals of US regulatory affairs, Regulatory Affairs Professionals Society. 

RAPS. Chapter 18. Good Laboratory Practices and Good Clinical Practices. In 2005 Fundamentals of US Regulatory Affairs. Rockville Regulatory Affairs Professional Society, 2005. 

Regulatory Affairs Professional Society. (Internet at http //www.raps.org/s raps/event session.asp TRACKID= CID=1912 DID =23891.)... 

Medicines Control Agency (MCA) National Institutes of Health National Library of Medicine Regulatory Affairs Professional... 

Regulatory Affairs Professional Society (RAPS). URL http // www.raps.org. The RAPS Web site is a good source of information on educational publications available for purchase, as well as forthcoming training seminars and professional conferences focused on regulatory topics. The Society s monthly journal and adjunct current awareness services are accessible only to members. 

Clinical research professional organization directories such as those of the Association of Clinical Research Professionals (ACRP), the Drug Information Association (DIA), the Regulatory Affairs Professional Society (RAPS). 

Regulatory Affairs Professionals Society Research Coordinating Committee (CDER) Remove Clinical Hold Randomized Clinical Trials Response to Request for Information (COMIS term) Remote Data Entry... 

GLP has had a big impact in ensuring the quality of regulatory submissions, and the authorities can now rely on the accuracy and integrity of the data presented. Regulatory affairs professionals also aim to ensure another aspect of this quality by providing the full set of information required, in the specified format and in a manner which is reviewer friendly . 

MiUer, L. L., Cocchetto, David M., The Regulatory Affairs Professional in the Hot Seat in the Drug Development Process, Drug Information Journal 31 805-823,1997. 

Regulatory Affairs Professionals Society www.raps.org/s raps/index.asp... 

Gaffney, A. (2015) India s data integrity problems. Regulatory Affairs Professionals Society, 3 Febmary 2015. Available from http //www.raps.org/Regulatory-Focus/News/2014/08/19/18980/lndias-Data-lntegrity-Problems-Updated-17-June-2014/ [accessed 3 May 2015]. 

---