FORUM INSTITUT
FORUM · Institut für Management GmbH
Vangerowstraße 18
69115 Heidelberg
Email: service@forum-institut.de
Phone: +49 6221 500-500
Fax: +49 6221 500-505
Course Vendor Oversight RA
How to establish a regulatory
vendor oversight programme
2018-12-08 2019-10-09 Adina Apartment Hotel Checkpoint Charlie Krausenstr. 35-36 10117 Berlin berlincc@adina.eu +49 30 200 767 0 +49 30 200 767 599

Vendor Oversight in a regulatory environment

Regulatory affairs, vigilance and other GxP areas

Effective oversight of outsourced activities in the healthcare sector - Prepare yourself for the balancing act between compliance and outsourcing, and learn how to implement your own effective regulatory vendor oversight programme.
Topics
  • Local vs global outsourcing
  • Quality management and quality assurance in outsourcing activities
  • How to implement an effective worldwide regulatory vendor oversight programme
  • Budget control and KPI monitoring
  • Legal, contractual and liability aspects

This distinguishes our event

100%
Overall impression: 100 % of the participants' feedback was very good or good (October 2018)
100%
Course content: 100 % of the participants' feedback was very good or good (October 2018)

Aims and objectives

Many healthcare companies are choosing to outsource regulated activities in regulatory affairs, vigilance and other GxP areas. They remain responsible for ensuring that the services are in compliance with contractual and regulatory requirements. Our seminar and workshop will explain how to implement an effective regulatory vendor oversight programme in your company and how to monitor quality, KPIs, budget and compliance.
Who should attend
This seminar addresses the needs of
those working in the pharma and
healthcare industries. It will particularly
benefit the following departments involved
in outsourced regulatory activities:
  • Regulatory Affairs;
  • Pharmacovigilance;
  • QA and QC; and
  • Business Development.
Providers are also invited to attend this
seminar to exchange experiences. The
optional workshop on day 2 will provide
practical insights into operational issues
and specific cases.
Your speakers
Speakers both days
Dr. Susanne Enslin
Lundbeck GmbH, Hamburg, Germany

Stephan Hütter
PharmaLex GmbH, Office Mannheim, Germany

Speaker day 1
Dr. Dr. Adem Koyuncu
Law firm Covington & Burling LLP, Brussels & Frankfurt


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Find out more on our international portfolio

Our international course portfolio

Are you interested in our international continuous education programme? We provide a variety of specialised courses for the healthcare industry.

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Abbreviations, Glossary

List of abbreviations

Many abbreviations for processes, documents and authorities, amongst others, are used in all regulatory areas. We have compiled the most important ones for you. Our list of abbreviations can be freely downloaded here.

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More on our quality criteria

Quality guaranteed!

IMI (Innovative Medicines Initiative) defined quality criteria for professional training and education. We follow these criteria and, as a signatory, we are an active partner in further developing and optimising the quality standards.

An aggregate evaluation of participants' feedback on all FORUM's healthcare training courses (evaluation period from 10.2016 - 09.2017) produced a result of 1.6 (based on a school grading system of 1-6).

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