The Impact of “Brexit” On Clinical Research – An Operational Readiness Primer

Teachers
Michael Pierro
Category:
Clinical Trials & Good Clinical Practices (GCP) Training/ On-Demand Courses/ Regulatory & Compliance/
Duration: 90 Minutes
On-Demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

On 23 June 2016, the United Kingdom (UK) voted to leave the European Union. This came on the heels of the implementation of the new EU Clinical Trials Regulation (EU No 536/2014). A year later, the planning for Brexit is beginning, but what that departure will mean for the pharmaceutical and biotechnology industries’ development and approval processes is still unclear.

What new or different regulations may be implemented to develop new medicinal products in the UK?  Will approval time slow down because of different requirements? What is the impact on pending reviews? What happens if the EMA relocates?

Most importantly, how can your organization comply with current EMA requirements and be ready for the transition?

Attend this 90-minute, interactive webinar to get an overview of the current EU clinical development environment and gain insight on the impact that Brexit will have.

 

LEARNING OBJECTIVES

At the completion of this session, attendees will be able to:

  1. Interpret EMA’s guidance for MAHs on what must be done to prepare for Brexit.
  2. Recognize changes in the regulatory requirements for submission and approval in the UK.
  3. Identify the impact on newly submitted MAAs’ and future approvals.
  4. Revise your development strategy and modify your business processes to prepare for the changes.

Who Should Attend

WHO SHOULD ATTEND

This course would benefit:

  • Clinical research professionals
  • Regulatory affairs team leaders
  • QA staff responsible for adherence to the regulatory requirements
  • Individuals responsible for SOP revision/development and submission of Clinical Trial Applications and Marketing Authorizations

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 and use Option 3 (9am – 5pm EST, M-F) for assistance.

About Instructors

Michael Pierro
Michael Pierro, a highly experienced facilitator and subject matter expert, provides clinical operations and GCP/SOP training to the biotechnology, CRO and pharmaceutical industry.

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