DIA’s 8th MIDDLE EAST REGULATORY CONFERENCE TO FOCUS ON IMPROVED ACCESS TO MEDICINES AND THERAPIES

DIA’s 8th MIDDLE EAST REGULATORY CONFERENCE TO FOCUS ON IMPROVED ACCESS TO MEDICINES AND THERAPIES

29/01/2009


BASEL, SWITZERLAND—20 JANUARY 2009—The Drug Information Association (DIA), the premier, multidisciplinary, non-profit association that provides a neutral forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes, will host the 8th Middle East Regulatory Conference (20-21 January 2009; Manama, Bahrain) Key stakeholders, including representatives from ministries of health, local and multinational pharmaceutical companies will exchange views, discuss topics of interest, and identify actions to increase patient access to new and improved medicines and therapies in the Middle East. The programme of this conference was discussed during a MERN / Health Authorities joint workshop that was held in November 2007, and the topics for the conference were identified during a Programme Advisors meeting held in April 2008, involving regulators of the region. Sessions topics include: • Local regulatory authority views and key issues • Pharmacovigilance • Pharmacoeconomics • Counterfeits • Innovation in the quality arena • Quality-by-design • Good Manufacturing Practices including PIC/S • Biologics • Evolving global legislation on medicines • Biosimilars • Common Technical Document and electronic submissions “Since its inception 13 years ago, the Middle East Regulatory Conference has grown to become an important forum for discussion of matters related to the provision of healthcare in the region, with a specific focus on issues around the evaluation and supervision of innovative medicines for human use,” says the chairperson of the MERN, Florence Roizard, Merck Sharp & Dohme, France. This is the 8th DIA Middle East Regulatory Conference in partnership with the Middle East Regulatory Network (MERN). The MERN is an ad hoc regional network of the EFPIA (European Federation of Pharmaceutical Industries and Associations). The MERN works in partnership with regulatory authorities and the pharmaceutical industry in the Middle East to develop legislation and regulatory practices that enable patients to have access to high quality innovative medicines. ### About the Drug Information Association (DIA) DIA serves more than 30,000 professionals in the biotechnology, pharmaceutical and regulatory industries worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham, PA (USA), and with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China, the Association is led by its volunteer-based Board of Directors and executive management team. For more information, visit www.diahome.org or call +1-215-442-6100.

Comments

Pharmacovigilance in Bahrain

By: user

29/12/2011 05:23:46 PM

Dear Sirs,

Please could you tell me the Pharmacovigilance requirement for a Pharmaceutical company with Pharmaceutical products on the Market in Bahrain.

Please could you tell me the following requirement?

What spontaneous adverse events from Bahrain need reporting? Is it within 15 days and is a CIOMS I form acceptable
What spontaneous adverse events from third countries need reporting? Is it within 15 days and is a CIOMS I form acceptable
What clinical trial serious adverse events from Bahrain need reporting? Is it within 15 days (for serious) and 7 (for death and life threatening) and is a CIOMS I form acceptable
What clinical trial serious adverse events from third countries need reporting? Is it within 15 days (for serious) and 7 (for death and life threatening) and is a CIOMS I form acceptable?

Finally do you require submission of PSURS and DSURS.

Thank you for your help with this enquiry?

Kind regards
Noelle

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