BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 15.4//EN BEGIN:VEVENT DESCRIPTION:June 18th 2015 ~ 8:30 &ndash\; 10:30 UK time 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 lin k. \nClinical 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 FD A (cFDA) and Japan&rsquo\;s Pharmaceutical and Medical Device Agency (PMDA ) providing both insights into the regulatory requirements\, real life exa mples of local development plans and key things to consider when looking t o include these countries in multi-regional trials. \; \; Statis tical Challengers and Opportunities on Multi-regional Clinical Trials Incl uding Asian Countries Dr. Dejun Tang \; (Novartis Pharma\; China) Mult i-regional trials are nowadays widely conducted and many multi-regional cl inical trials are carried out including Asian countries. However\, along w ith new opportunities\, there are many challenges on scientific\, operatio nal\, and regulatory aspects for conducting such trials. This presentation will discuss both statistical challenges and opportunities on planning an d conducting the multi-regional clinical trials which involve Asian countr ies. Several examples in some clinical trials will be provided for discuss ion to illustrate the issues and possible solutions. Evaluation of a Multi -regional Trial for Global Simultaneous Drug Development Dr. Norisuke Kawa i &ndash\; (Pfizer Japan Inc.) In recent years\, multi-regional trials (MR CTs) are becoming common for drug development in Japan. The primary object ive of MRCT is to evaluate efficacy and safety of the study drug in the ov erall study population. An important secondary objective of MRCT is to eva luate 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\, ho w 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 i nfluence 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 s ome statistical approaches for exploring regional heterogeneity of the tre atment effect. Points to Consider in Regional Study Design Dr. Nicole F. Li &ndash\; (Roche\; China) ICH E5 stated that data developed in one regi on can be possibly extrapolated to the new region if a bridging study show s evidence that the drug will behave similarly across regions. However\, & ldquo\;Similarity&rdquo\; of efficacy across regions is not clearly define d in ICH E5 guideline. There is lack of regulatory guideline on defining & ldquo\;consistency&rdquo\; in bridging study\, and no commonly accepted st atistical inference in demonstrating &ldquo\;consistency&rdquo\;. 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 criter ia\, and key considerations on sample size. We do encourage your participa tion. If you have questions relating to the Asia-Pacific Development \ ; webinar\, ahead of the webinar\, please email them to \;Sajda.Ghani@ covance.com \;or jennifer.gilbride@grunenthal.com We will do our best to discuss them at the webinar. \nTo register please click here. DTEND;VALUE=DATE:20150619 DTSTAMP:20260720T134538Z DTSTART;VALUE=DATE:20150618 LOCATION: SEQUENCE:0 SUMMARY:PSI Scientific Committee Webinar: Drug Development beyond the FDA/E MA – Opportunities and Challenges in Asia Pacific Development Pathways UID:RFCALITEM639201519387824719 X-ALT-DESC;FMTTYPE=text/html:

June 18th 2015 ~ 8:30 &ndash\; 10:3 0 UK time

Registration fee: None

The webinar is free of charge. However\, attendees must register on t he PSI website in order to obtain the dial-in details and the webinar link .

\nClinical drug development has often had a heavy focus on t he needs of the FDA and EMEA. This webinar aims to focus on the needs of t he China FDA (cFDA) and Japan&rsquo\;s Pharmaceutical and Medical Device A gency (PMDA) providing both insights into the regulatory requirements\, re al life examples of local development plans and key things to consider whe n looking to include these countries in multi-regional trials. \;  \;

Statistical Challengers and Opportunities on Mult i-regional Clinical Trials Including Asian Countries
Dr . Dejun Tang \; (Novartis Pharma\; China)

Multi-regional t rials are nowadays widely conducted and many multi-regional clinical trial s are carried out including Asian countries. However\, along with new oppo rtunities\, there are many challenges on scientific\, operational\, and re gulatory aspects for conducting such trials. This presentation will discus s 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 illus trate the issues and possible solutions.

Evaluation of a Mu lti-regional Trial for Global Simultaneous Drug Development
Dr. Norisuke Kawai &ndash\; (Pfizer Japan Inc.)

In recent years\, multi-regional trials (MRCTs) are becoming common for drug develo pment in Japan. The primary objective of MRCT is to evaluate efficacy and safety of the study drug in the overall study population. An important sec ondary objective of MRCT is to evaluate influential ethnic factors on effi cacy and safety of the study drug. It includes investigating whether there is heterogeneity across regions. In this presentation we will discuss a f ramework\, 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 categor ized into three layers: Layer 1 to first look at overall study results\, L ayer 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 a uthorities. We will also discuss some statistical approaches for exploring regional heterogeneity of the treatment effect.

Poin ts to Consider in Regional Study Design
Dr. Nicole F. Li &ndash\; (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\, &ldquo\;Similarity&rdquo\; of efficacy across regions is not cle arly defined in ICH E5 guideline. There is lack of regulatory guideline on defining &ldquo\;consistency&rdquo\; in bridging study\, and no commonly accepted statistical inference in demonstrating &ldquo\;consistency&rdquo\ ;. Our work provided statistical\, regulatory\, clinical considerations an d guidance on design and analysis of efficacy bridging trials\, and explor ed how the primary objective should be defined\, how to select the consist ency criteria\, and key considerations on sample size.

We do encour age your participation. If you have questions relating to the Asia-Pacific Development \; webinar\, ahead of the webinar\, please email them to& nbsp\;Sajda.Ghani@covance.com  \;or jennifer.gilbride@grunenthal.com

We wi ll do our best to discuss them at the webinar.

\nTo register p lease click here.

END:VEVENT END:VCALENDAR