Already a DIA Member? Sign in. Not a member? Join.

Iniciar sesión

¿Ha olvidado su ID de usuario? or ¿Ha olvidado su contraseña?

Not a Member?

Create Account and Join

Bethesda North Marriott Hotel and Conference Center

05 feb 2018 7:00 a.m. - 07 feb 2018 3:00 p.m.

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Session 7 Track 3: Understanding ICH E6 R2 and the Impact to Clinical Trial Documentation and the Trial Master File

Session Chair(s)

Joanne  Malia, MS, MSc

Joanne Malia, MS, MSc

Director, Development Records Management

Regeneron Pharmaceuticals, United States

ICH E6 R2 was released in November 2016 and has outlined new expectations for all stakeholders of clinical trials. Additionally, the EMA released its draft guidance on the TMF. This session will discuss the resulting expectations impacting clinical trial documentation and the Trial Master File (TMF). The impact and response from different stakeholders such as vendors, sponsors, and regulators will be presented and discussed.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Understand new and coming expectations for TMF management due to ICH E6 R2 and EMA draft TMF guidance
  • Distinguish draft EMA TMF Guidance boundaries from inspection requirements
  • Recognize and take away practical strategies for eTMF compliance to regulations

Speaker(s)

Fran  Ross

eTMF Compliance: Impact of ICH E6 R2 Update and EMA Draft TMF Guidance

Fran Ross

Advanced Clinical, United States

Practice Director, Trial Master File

Joanne  Malia, MS, MSc

Speaker

Joanne Malia, MS, MSc

Regeneron Pharmaceuticals, United States

Director, Development Records Management

Ann  McCabe

Speaker

Ann McCabe

Daiichi Sankyo Inc, United States

Director, Process Excellence and Risk Management

Representative Invited

Speaker

Representative Invited

FDA, United States

¿Tiene una cuenta?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.