EMA and MHRA Inspections: Successful Planning and Execution Tips and Techniques

Course Description

In recent years, the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have increased the frequency and reach of their inspections. The outcome of the inspection can determine whether a product will be granted a marketing authorization in Europe or the UK, and good preparation will enable the research to be shown in the most favorable light. This web seminar will help learners to know how best to prepare their organizations for inspections by the EMA and MHRA inspectorates, to know what the inspectors are looking for, to understand what to expect during the inspection and to learn from real inspection experiences.

Learning Objectives

• Describe how to be inspection ready at all times
• Explain the differences between EMA and MHRA inspections, and their significance
• Identify tools to prepare the organization to perform at its best during the inspection
• Describe how to mitigate inspection findings
• Identify which records should be made available for the inspection

Who Should Attend

• Clinical Operations Staff
• Facilitators of the inspection
• Senior Management Personnel who have a role in the inspection

Instructor

The course will be led by one of the following instructors:

Elizabeth Ronk Nelson, M.P.H.

Vaska Tone

Click here for complete trainer biographies

Registration Fees

$945

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 3 hours (0.3 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-22-007-L04-P. Released: 6/22. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.