11 March, 2008 - 13 March, 2008
5th IFPMA Asian Regulatory Conference
Kuala Lumpur, Malaysia
The 5th IFPMA Asian Regulatory Conference, held in 2008 in Malaysia, was organised by the IFPMA in co-operation with the Ministry of Health of Malaysia, in collaboration with the World Health Organization and with support from the Pharmaceutical Association of Malaysia (PhAMA).
IFPMA Director General Dr. Harvey Bale said: “A number of Asian countries are not only growing pharmaceutical markets, but also increasingly important locations for pharmaceutical R&D. This dynamism presents a major challenge to government regulators and industry alike, to ensure best utilization of available resources and expertise, to ensure the appropriate, competent oversight and regulation needed to allow new products to be made available to patients in a safe, timely manner.”
The 5th conference program covered the following topics:
ICH and its ICH GCG: how Asia fits into the global picture?
Good Regulatory Practices: are agencies ready?
Quality: how to ensure quality of products?
Association of South East Asian Nations harmonisation: current status and future perspectives
Global drug development
Pharmacovigilance and maintenance of product information
Future regulatory challenges: is Asia ready?
It was attended by over 300 delegates from health ministries and regulatory authorities of all Asian countries, as well from all the ICH regions, international organizations and the pharmaceutical industry.