This
web seminar covers the sponsor’s responsibilities for the conduct of a global
drug study. Participants will learn the 23 responsibilities assigned to a
sponsor for a global clinical study based on the International Council for
Harmonization (ICH) requirements. These essential requirements for compliance
to regulations are useful when dealing with the FDA, Medicines and Healthcare
Products Regulatory Agency (MHRA), European Medicines Agency (EMA), and Health
Canada (HC), among other global regulatory authorities. Focusing on the
importance of documentation, participants will learn how to put these concepts
into practice.
- Discuss the 23 sponsor responsibilities assigned
in ICH GCP E6 Guideline and expected by the regulatory authorities across
the globe
- Describe how these concepts are put
into practice, with special focus on documentation to support sponsor
oversight of these responsibilities
- Clinical Operations Staff
- Project Managers
- Regulatory Affairs Professionals
- Quality Assurance Personnel
- All other personnel responsible for ensuring
compliance with sponsor responsibilities in the conduct of a clinical
trial (especially for start-up and smaller biotech companies)
Debbie Harper, B.Sc., P.M.P.
Click here for complete trainer
biographies
$735
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 1.5 hours (0.15 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#: 0778-0000-18-051-L01-P.
Released: 12/18.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.