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PSI Scientific Committee Webinar: Drug Development beyond the FDA/EMA – Opportunities and Challenges in Asia Pacific Development Pathways - 16th July @ 8:30am (UK) *Registration fee: None* The webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link. Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials. *Statistical Challengers and Opportunities on Multi-regional Clinical Trials Including Asian Countries* *Dr. Dejun Tang (Novartis Pharma; China)* Multi-regional trials are nowadays widely conducted and many multi-regional clinical trials are carried out including Asian countries. However, along with new opportunities, there are many challenges on scientific, operational, and regulatory aspects for conducting such trials. This presentation will discuss both statistical challenges and opportunities on planning and conducting the multi-regional clinical trials which involve Asian countries. Several examples in some clinical trials will be provided for discussion to illustrate the issues and possible solutions. *Evaluation of a Multi-regional Trial for Global Simultaneous Drug Development* *Dr. Norisuke Kawai – (Pfizer Japan Inc.)* In recent years, multi-regional trials (MRCTs) are becoming common for drug development in Japan. The primary objective of MRCT is to evaluate efficacy and safety of the study drug in the overall study population. An important secondary objective of MRCT is to evaluate influential ethnic factors on efficacy and safety of the study drug. It includes investigating whether there is heterogeneity across regions. In this presentation we will discuss a framework, that is, a three-layer approach, to evaluate data from a MRCT. In the three-layer approach, how to interpret data in a MRCT is categorized into three layers: Layer 1 to first look at overall study results, Layer 2 to identify factors which influence overall results from scientific and regulatory perspectives, and Layer 3 to evaluate benefit/risk for a specific country/ region according to the requirements of its regulatory authorities. We will also discuss some statistical approaches for exploring regional heterogeneity of the treatment effect. *Points to Consider in Regional Study Design* *Dr. Nicole F. Li – (Roche; China)* ICH E5 stated that data developed in one region can be possibly extrapolated to the new region if a bridging study shows evidence that the drug will behave similarly across regions. However, “Similarity” of efficacy across regions is not clearly defined in ICH E5 guideline. There is lack of regulatory guideline on defining “consistency” in bridging study, and no commonly accepted statistical inference in demonstrating “consistency”. Our work provided statistical, regulatory, clinical considerations and guidance on design and analysis of efficacy bridging trials, and explored how the primary objective should be defined, how to select the consistency criteria, and key considerations on sample size. We do encourage your participation. If you have questions relating to the Asia-Pacific Development webinar, ahead of the webinar, please email them to [log in to unmask] [log in to unmask] You may leave the list at any time by sending the command SIGNOFF allstat to [log in to unmask], leaving the subject line blank.