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FDA/CDER: 2018 Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program

SUMMARY: The Center for Drug Evaluation and Research (CDER) in the Food and Drug Administration (FDA) is announcing the 2018 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. The purpose of this document is to invite pharmaceutical companies interested in participating in this program to submit a site visit proposal to CDER’s OPQ.

DATES: Submit either an electronic or written proposal to participate in this program by February 2, 2018. See section IV of this document for information on what to include in such proposals.

For more go to information https://www.gpo.gov/fdsys/pkg/FR-2017-12-04/pdf/2017-26055.pdf

 

 
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Cooperation to strengthen Traditional Medicine and Complementary Therapies

Since the proposal to build the VHL Traditional Medicine and Complementary Therapies (TM&C VHL) was presented in Nicaragua, in the beginning of 2017, during the meeting “Advancing towards Universal Health: contributions of Traditional and Complementary Medicine”, many important steps have been taken to expand collaboration and development of the TM&C VHL.

In fact, the enthusiasm of the TM&C Regional Network, which has representatives of organizations from several countries, as well as the leadership of PAHO/WHO Health Services Unit, and the technical cooperation of BIREME, have been the facilitating elements for the fast development of this VHL.

For more information go to http://boletin.bireme.org/en/2017/11/29/cooperation-to-strengthen-traditional-medicine-and-complementary-therapies/

 
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INVIMA HAS BEEN ACCEPTED AS AN OBSERVER TO THE ICH

The ICH Assembly announced the acceptance of Invima as the new observer of the ICH in an official communication.

The International Council for the Harmonization of Technical Requirements for Pharmaceutical Products (ICH) is an initiative with 25 years of existence, unique in bringing together regulatory authorities and the pharmaceutical industry to work on regulatory convergence and development processes of International guidelines of reference on the scientific and technical aspects of the registration of medicines.

More information available by the link https://www.invima.gov.co/images/pdf/informate/Ingreso-Invima-observador-ICH-FINAL.pdf

 

 
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WHO First round public consultation: Recommendations to assure the quality, safety and efficacy of hepatitis E vaccines (deadline 12 February 2018)

The World Health Organization posted on WHO biological website (http://www.who.int/biologicals/en/) the first round public information related to recommendations to assure the quality, safety and efficacy of hepatitis E vaccines . The new recommendations are available at http://www.who.int/biologicals/vaccines/HEP_E_VACCINES_Recommendations_draft_1_public_consultation.pdf?ua=1.

A comment form on hepatitis E vaccines is downloadable from the website next to the document until 12 February 2018.

The current draft recommendations was prepared based on the discussion and consensus reached by the experts from regulators, industry and academia, in the working group meeting in May 2017 and subsequent review and comments of a initial draft by the working group participants over past months.

WHO are seeking for your critical review and comments/suggestions on this document for further development and improvement. Please would you send your comments or comments from your colleagues who are involved in regulation or responsible for manufacturing and quality control of hepatitis E vaccines by using the “comment form” on the web by 12 February 2018 to leid@who.int . Your comments will be reviewed by an informal consultation and incorporated into next version of the Recommendations as appropriate. Finally the Recommendations will be submitted to ECBS for review and adoption in its meeting in October 2018.

Source: Dianliang LEI PhD, Scientist Technologies, Standards and Norms, Essential Medicines and Health Products, World Health Organization. Email: leid@who.int