APEC Pilot CoE Training on MRCT and GCP at Harvard University, April 10-13, 2018
Progress: 
 
Application
 
Background
Consistent with the goals of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), regulatory authorities worldwide aim to ensure that drugs are developed by processes that uphold the highest ethical standards and scientific principles. Those developing and conducting high quality clinical trials depend upon consensus understanding of the principles underlying drug development, clinical and research practices, regulatory review of submitted data, regulatory inspections, and post-approval monitoring. Harmonized technical guidelines to which global regulators commit can speed the process for efficient and effective registration, approval, and monitoring. A shared interpretation of these guidelines is essential to a cooperative and global effort to promote and protect public health.
 
That said, clinical research and clinical trials are not stagnant. The evolution of research technologies (e.g. electronic data sources, risk-based monitoring) and study design (e.g. adaptive trials) render periodic review and adaptation of the ICH guidelines necessary. In December 2016, a comprehensive revision of ICH E6, Guideline for Good Clinical Practice (GCP), termed ICH E6(R2) was adopted; ICH E6 was "amended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results." In December 2017, ICH E17 was issued to provide general principles on planning and designing Multi-Regional Clinical Trials (MRCTs). It is important that the international regulatory community understand these guidelines, share a common interpretation, and are familiar with approaches and implementation. 
 
APEC Pilot CoE Training on Multi-Regional Clinical Trials (MRCTs) and Good Clinical Practice (GCP), Hosted by MRCT Center of Brigham and Women's Hospital and Harvard University

This Asia-Pacific Economic Cooperation (APEC) Pilot Center of Excellence (CoE) training program is a workshop specifically designed for regulators with responsibility for multi-regional clinical trials, drug review and approval. The workshop goals are to advance the understanding of the ICH E17 (Multi-Regional Clinical Trials) and ICH E6 (Good Clinical Practice) guidelines to facilitate their adoption and implementation. Case-based learning, presentations, and open discussion of scientific, statistical, and practical approaches will be used. The Faculty will include regulators from the USFDA, EMA and others with the assistance of academic and industry leaders. All sessions will be conducted in English.

When: April 10-13, 2018
Where: Harvard University, Cambridge, MA USA
 
Learning Objectives for APEC Pilot CoE Training Program
  • Enhance regulatory cooperation in the APEC region on the evaluation and regulation of MRCTs
  • Increase the acceptability of MRCT data by multiple regulatory authorities
  • Describe the concepts of MRCTs and key considerations in MRCT design as presented in ICH E17 guidance
  • Demonstrate practical approaches to fulfilling the requirements of GCP as presented in ICH E6(R2)
 
Wherever possible, use of case studies and active learning modalities will be employed.
 
This course is free to attend for governmental regulators, but individual participant expenses other than registration will not be covered. Governmental regulators and academic representatives from APEC travel-eligible economies may be eligible for travel assistance from the APEC Harmonization Center, and will be given priority upon registration. To apply for travel assistance, if eligible, please contact APEC Harmonization Center (AHC) at ahckorea@kpbma.or.kr prior to March 10, 2018.  
 
Participants from industry and private sector will incur a fee of US$ 2,995, and participants from academia will incur a fee of US$1,495. Sponsors of the MRCT Center are entitled to a 20% discount. Partial waivers will be considered on a case-by-case basis. Please contact us at mrct@bwh.harvard.edu for more information.  

Attendance at all three and one half days is mandatory, and a certificate of completion will be awarded at the completion of the training.

An agenda is forthcoming.
<