DIA-US FDA-EMA-MHRA-CDSCO Clinical Trials Workshop - Regulatory Expectations and Data Quality in the time of COVID-19 and Beyond

Perspectiva general

U.S. Food and Drug Administration India Office and DIA India Office will host a 2-day workshop on guidance, policies, and findings of clinical trials from the US Food and Drug Administration (USFDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA) and Central Drugs Standard Control Organisation (CDSCO).

This joint program offers a unique opportunity to hear from expert regulators from USFDA, MHRA, EMA and the CDSCO on current perspectives of clinical trials. There will be Q&A sessions with experts from USFDA, EMA, MHRA and CDSCO who will share experiences and views of the global clinical trial environment.

This two-day workshop will have sessions on clinical trials in the time of COVID-19, regulatory guidance and expectations for conduct of clinical trials and panel discussions.

Objetivos de aprendizaje

The objective of this workshop is to publicize agencies’ thinking on current issues and promote active dialogue to facilitate understanding of regulatory expectations.

This workshop will focus on the importance of sponsor oversight of clinical sites and laboratories, source data (including electronic health records), protocol deviations due to the COVID-19 pandemic (including the impact on clinical trials and the challenges in ensuring data quality in clinical trials).

Workshop participants will have opportunities to ask questions of the represented regulatory agencies.

Comité del programa

Sarah E McMullen Director
HEALTH AND HUMAN SERVICES / FOOD AND DRUG ADMINISTRATION , OC/OPLIA/OGPS/ IO, India
Sudheendra Kulkarni Senior Technical Advisor,
FDA, India
SeongEun Cho Director
FDA, United States
Barbara D Wright Supervisory Investigator, Foreign Inspection Cadre, Office of Bioresearch Monito
FDA, United States
Sarah Ibrahim, PHARMD, PHD Associate Director for Stakeholder and Global Engagement, Office of Generic Drug
FDA, United States
Nilufer Tampal, PHD Acting Associate Director for Scientific Quality in OGD’s Office of
FDA Bioequivalence, United States
Rubina Bose Deputy Drugs Controller (India)
CDSCO (West Zone), India
Lisbeth Bregnhøj, PHD, MPHARM EC ICH E6(R3) Expert Working Group Member
The Danish Medicines Agency, Denmark
Stephen Vinter Head of Compliance
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

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DIA-US FDA-EMA-MHRA-CDSCO Clinical Trials Workshop - Regulatory Expectations and Data Quality in the time of COVID-19 and Beyond

Perspectiva general

Objetivos de aprendizaje

Comité del programa

Digital Learning Catalog

Be informed and stay engaged.