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LATEST NEWS


Draft regulations for registration of medical devices in South Africa
The South African regulatory authority has revised regulations relating to the registration of medical devices in the country. The draft regulations which were released for comment will significantly change the registration process in the country with a more comprehensive dossier being required for the process. The comment period has now closed. Please see the attached file here.

Complementary and Alternative Medicines Registration in South Africa - Request for review of regulations from industry group
The release in November 2013 of the regulations for registration of Complementary and Alternative Medicines in South Africa has resulted in much debate in the industry. Representations have been made by various groups within the industry to the Medicines Control Council for clarification for amendments to the regulations, a copy of which can be accessed here . Comments can be forwarded to the discussion group directly - details can be found on page 14 of the document.

17th World congress of Basic and Clinical Pharmacology in Cape Town
The Congress will be held from 13-18 July 2014 in Cape Town, South Africa. There is an excellent scientific programme as well as a variety of pre- and post-congress satellite meetings. The Congress will be opened by Nobel Laureate for Chemistry 2012, Dr. Robert Lefkowitz, Professor at Duke University Medical Center, brings together some of the world's leading pharmacologists and is a unique networking opportunity. More information can be found in the attached link or at www.wcp2014.org

FDA: Draft Guidelines for clinical pharmacology data to support biosimilarity
On 9 May 2014, the FDA released for comment a draft guidance for clinical pharmacology data required to demonstrate biosimilarity to a reference product. The Guidance expands on the 2012 document and should provide drug developers a more structured roadmap in the development of biosimilars. The guidance can be accessed here .

And now for something completely different…
Anyone who knows me knows that I'm fascinated by the cosmos and anything that relates to it….. have a look at the YouTube item by Neil deGrasse Tyson on Can fish swim in space? Enjoy Star Trek Radio!

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About Denise Richardt Consulting

After 20 years working at various levels of the drug development process, Denise Richardt Consulting (DRConsulting) was established as an independent consulting service in 2012, providing support to predominantly pharmaceutical and medical device companies. Complementary and Alternative Medicine development and registration has now been added to the scope of services offered.

For more information about Denise Richardt, please visit her LinkedIn Profile.

Outsourcing

In addition to providing regulatory affairs and registration services, DRConsulting has alliances with other independent consultants offering services in

  • trial management and monitoring
  • translation services
  • investigational product management

All contractors and consultants are supervised and project managed by DRConsulting and have been vetted by DRConsulting.

 
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