Focus Area: Capacity Building

In April 2018, the MRCT Center held a 3 1/2-day training workshop at the Harvard Faculty Club focused on Multi-Regional Clinical Trials (MRCT) and Good Clinical Practice (GCP) as an APEC (Asia-Pacific Economic Cooperation) Pilot Center of Excellence (CoE), and specifically on ICH-E17 and ICH-E6(R2).

Twenty-two professionals from twelve economies participated, and all but one were governmental regulators.  Senior staff from the U.S. Food and Drug Administration (FDA), Health Canada, Health Products Regulatory Authority (HPRA) Ireland, Pharmaceuticals and Medical Devices Agency (PMDA) Japan, industry partners, PhRMA, and MRCT Center facilitated the interactive sessions.  The training was co-hosted by the APEC Harmonization Center (AHC).

 The objectives of the workshop were to:

• Enhance regulatory cooperation in the APEC region on the evaluation and regulation of MRCTs
• Demonstrate practical approaches to fulfilling the requirements of GCP as presented in ICH E6(R2)
• Describe the concepts of MRCTs and key considerations in MRCT design as presented in ICH E 17 guidance
• Increase the acceptability of MRCT data by multiple regulatory authorities

With near unanimity, the participants rated the program as “excellent,” including the organization of the training, the faculty lectures, case studies/breakout groups, question and answer and “ask the expert” sessions, and the course materials. The vast majority of participants agreed that the training increased their knowledge and understanding of MRCTs and GCP and that the knowledge or techniques gained from this training will be practically useful in their field.  Participants found the faculty knowledgeable of their respective training topics and networking with other participants was helpful. Based on this training, participants envisioned what they will do differently when they go back to their place of work.

The MRCT Center held a 3-day training workshop on International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guideline E6(R2) at Harvard Faculty Club last month.

Twenty-five professionals from fourteen countries participated, approximately half were governmental regulators. Senior staff from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), industry partners and MRCT Center facilitated the interactive sessions.

The objectives of the workshop were to:

• Describe the standards of Good Clinical Practice (GCP) as set out in ICH E6 as well as the changes in the ICH E6(R2) revision, as applied to multinational design, conduct, oversight, reporting and review of regulated trials
• Describe models of implementation of the changes in the ICH E6(R2) addendum
• Demonstrate practical approaches to fulfilling the requirements of ICH E6(R2) consistent with revised standards (e.g., risk-based quality management).
• Describe and demonstrate best practices to assess clinical trial regulatory submissions, including study design, data packages, essential documents, reports, and filings for alignment with ICH GCP
• Define inspection methodologies to assess clinical trial conduct for alignment with ICH GCP including review of corrective actions.

With near unanimity, the participants rated the program as “excellent,” including the overall quality of the training, the quality of instruction and the course materials and case studies, the ability and opportunity to get questions answered and to interact, and the ability to gain a better understanding of the topic that will help them to implement these concepts. Participants said that the training improved their skills in GCP, gave them a better understanding of the overall conducting of clinical trials and a better understanding for interpretation of the data. Participants appreciated the opportunity to exchange experiences with colleagues from other countries and to ask questions of regulators.