E-DRUG: Education in regulatory sciences
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Dear e-druggers,
As part of a team, I am currently working on an assignment with the South
African National Department of Health on their proposal to establish an
institute of health product regulatory sciences.
The team has been investigating the availability of education in health
product regulation (not health technology regulation) to up-skill existing
staff members of a government health product regulatory agency, and also to
equip new staff being recruited with the expertise to be able to
immediately evaluate dossiers concerning health products (e.g. medicines
[human and veterinary], medical devices and in-vitro diagnostics,
complementary medicines, cosmetics, food safety, African traditional
medicines etc.). In addition, it is hoped to improve the interface between
industry and regulator so that education could also be made available to
the industry to meet their particular needs.
The team has undertaken literature and internet research and met with
identified stakeholders in South Africa. We have explored the current
availability of university programs and courses which mainly seem to be
addressed to the needs of the industry, rather than to the needs of
the regulator.
My question now is "does any country have such an institute of regulatory
science education which could be a model for South Africa? If so, what is
the mandate and role of this institute?"
I would be very pleased to receive comment.
Kind regards,
Murray Bailey
--
Independent Consultant
Pharmaceutical Policy, Systems, Implementation and Public Health
Development.
Email: pharmdevelop@gmail.com
E-DRUG: Education in regulatory sciences (2)
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Dear Murray,
Thank you for the information, i believe the initiative is worth
undertaking. For us in Liberia, there is no institute of Regulatory
Sciences. This concept is one of the issues we have proposed and
shared with the School of Pharmacy to begin looking at and to see how
best it could be included in our curriculum.
The issue of medicines safety in Liberia is one major concern that
needs serious attention and I am of the opinion that regulatory
sciences could address some of these concerns when included in our
medical curriculum where Medicines safety (pharmacovigilance) could
also be treated as well.
James Goteh
Liberia
James Goteh <jgoteh@gmail.com>
E-DRUG: Education in regulatory sciences (3)
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Hi Murray,
I believe there may be several activities underway in the area you mention. I expect you may have already come across it in the course of your team's investigation, but if not one activity to look into is the good work being done by US Pharmacopoeia to establish the Center for Pharmaceutical Advancement and Training (CePAT) in Ghana. CePAT is focused on building the capacity and skills of national and local regulatory authorities, quality assurance professionals, manufacturers, and others in the pharmaceutical industry by offering classes on dossier evaluation, medicines registration, Good Manufacturing Practices and other topics to help improve access to good quality medicines.
E-DRUG: Education in regulatory sciences (4)
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Dear Murray,
This is very good strategy to increase the availability of Qualified
experts for Regulatory Sciences. I like it personally.
In Tanzania, there is no such kind of Institute that provide "heavy"
regulatory sciences. However Muhimbili University of Health and Allied
Sciences (MUHAS), provide just as semester subject through 2 years program
of * Masters of Science in Pharmaceutical Management.* This education is
mainly supported by Tanzania Food and Drug Authority *(TFDA) *as one of
many strategies it use to increase availability of qualified experts in
Dossier in Regulation of Medicines and food in terms of safety, quality and
effectiveness, apart from special two weeks fresh training for the
experienced pharmacists and other on-job training, and so forth. Well done
to TFDA for its ongoing efforts.
Despite of this efforts, i see this idea of having institute as one of very
practical solutions that will strengthen our National Medicines Regulatory
bodies in terms of availability of qualified technical human resources, not
only in Tanzania but also in Africa. However program curriculum and future
context matters a lot for more professionals to be attracted.
Thank you.
Richard Silumbe
ADDO Program Coordinator,
Pharmacy Council of Tanzania
+255-713-481467
Richard Silumbe <rsilumbe@gmail.com>
E-DRUG: Education in regulatory sciences (6)
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Dear Murray,
Your question is very interesting.
Probably your question is about to build a curricula to improve capabilities in good review practice and good regulatory practice.
In APEC -AHC web site you can see many activities and presentations to improve regulatory convergence and interaction industry -regulators. http://www.nifds.go.kr/apec/index.do
Regards,
Hans Vasquez MD, MPH
Senior Clinical Reviewer
DIGEMID
Ministry of Health
Lima - Perú
Hans <hvasquezhans@yahoo.com>