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.
- 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
- Clinical Operations Staff
- Facilitators of the inspection
- Senior Management Personnel who have
a role in the inspection
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
$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.
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#: 0778-0000-19-009-L01-P.
Released: 6/19.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.