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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Draft Guidelines for clinical pharmacology data to support biosimilarity On 9 May 2014, the FDA released for comment a draft guidance for clinical pharmacology data required to demonstrate biosimilarity to a reference product.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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ICH-GCP Training: (includes additional South African GCP components)

Basic Introductory Course:

Duration: 2 full days (Please note that this course can be offered in a modular manner over a few evenings for groups who cannot accommodate the two days to attend the course)
Emphasis on theory with practical, real life applications and workshops
End of course written examination to evaluate competency for immediate certification

A basic comprehensive introductory course is provided over two days to initiate site personnel into the clinical trial process. The emphasis is on theory with practical real-life applications and workshops which assist the students in applying the principles of GCP in their own practices. All delegates are required to complete a test to evaluate knowledge competency.

Refresher Course:

For staff who have previously completed a basic introductory course; in South Africa, GCP training expires three years after the initial date of training.
Duration: six (6) hours
Re-certification valid for three (3) years

GCP training expires three years after the initial date of training (or last refresher) and refresher courses are available for experienced staff. The format of this course follows a more in-depth presentation of current information and legislation including South African, FDA and EU updates to broaden the knowledge base of the participants, while reinforcing basic principles.

Denise Richardt is an accredited ICH/SA-GCP trainer for clinicians and research site staff according to South African guidelines.

Training is provided on an ad hoc basis. If you are interested in scheduling a GCP course for yourself or your organization please complete a request on the Contact page.


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