Event Information

Time：October 7, 2014 (Tuesday) 03:00-05:00 p.m.

Place：TRPMA Conference Room
（1F, No. 465-1, Sec. 6, Zhongxiao E. Rd., Nangang Dist., Taipei City 11557, Taiwan）

The TRPMA was honoured to invite Dr Chen Min-Chu to give a special speech at the TRPMA on the Strategies and tools for pre-marketing drug safety planning. Dr Chen used to work in the US FDA as a head of the drug safety department. She has long experiences in the management of drug safety issues. Dr Chen mentioned that drug developers must gather drug safety information and formulate a sound drug safety management strategy in every clinical trial stage throughout the new drug development process. At present, the drug safety management in Taiwan focuses mainly on post-marketing pharmacovigilance. Drug developers should consider drug safety issues prior to marketing. Drug developers should identify and gather drug safety information and work out the Risk Minimization Plan in the early stage of the drug development process. A systematic drug risk management proposal should be in place as early as possible.

During the drug development process, developers are already able to predict potential adverse drug events (ADEs) and their possible causes. Developers should, therefore, work out a risk management plan to minimize the risk of ADEs. The plan should be revised at the detection of any unexpected new risks after the drug is on the market. Post-marketing pharmacovigilance is based on health professionals’ reports on a voluntary basis. The US FDA has established a sentinel initiative system to pro-actively monitor the drug safety information. Dr Chen hopes the authorities in Taiwan could properly use the ADR databank and the NHI databank to develop a post-marketing drug safety surveillance system in order to collect drug safety information in a timely manner.

New drug developers should also establish a safety monitoring system according to the Good Pharmacovigilance Practice (GPvP). Alternatively, they could refer to the Guidance for Industry - Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment Guidance issued by the US FDA in 2005 to take appropriate measures to assure the safety of their products. The submission of a Pharmacovigilance Plan (PV Plan) is required for all NDAs in the US, as well as in the EU. Drug developers in Taiwan aiming at the global market must draw up a PV Plan.

It is essential for new drug developers to create an internal drug safety system that covers the assessment, planning and management of drug safety issues. Therefore, in the second seminar of the course which is scheduled on October 27at 15:00-17:00, Dr Chen will provide practical instructions on how to set up an in-house drug safety department. All members are welcome to register for the course.

The TRPMA was honoured to invite Dr Chen Min-Chu to give a special speech at the TRPMA on the Strategies and tools for pre-marketing drug safety planning.