Summary
Are you compliant with the ICH GCP E6 Guideline R2 revisions on sponsors, sites, Contract Research Organisations and Vendors? And are you confident in your interaction with CROs?
This Diploma consists of two modules that together provide you with deep knowledge about how you comply with ICH GCP E6 Guideline R2. You also gain confidence in ensuring oversight of any trial-related duties and functions carried out on your behalf, including those that are subcontracted to another party by the sponsor’s contracted CRO(s).
Among other things, you learn to foresee potential misunderstandings and issues. This will enable you to improve relations with vendors and ensure good results.
Sign up now and bring a colleague: two participants for the price of one.
Key words
- Clinical outsourcing management
- Vendor oversight
- Conflict management
- Clinical trials
- Risk management
- RBQM
- Negotiation techniques
- Financial negotiation
- Legal contracts
- CSR
- HCP transparency
- Compliance
- Vendor Governance
- Investigator agreements
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Course leader(s) & Lecturers
- Rikke WintherCourse leaderOwner
WIN Outsourcing Consult - Claudia Blomgren-HansenLecturerOwner
LIFE SCIENCE PLUS Advokater - Desiree HammerstadLecturerSenior CRO & Planning Manager
Y-mAbs Therapeutics A/S - Pia Sauer LarsenLecturerSnr. Outsourcing Manager
NOVO NORDISK A/S - Andrea Beltrán OlesenLecturerSenior Manager Head of Clinical Partnership Management.
LEO PHARMA A/S - Gertrud Koefoed RasmussenLecturerHead of Clinical Operations
Vaccibody Denmark A/S - Kristine Dalsgaard CohenLecturerAssistant Director R & D Contract Management
Genmab A/S - Anders BeltoftLecturerSr. Director Business Development
Cerba Research
IS THIS COURSE FOR YOU?
The Diploma is right for you if your responsibilities include working, interacting and/or negotiating with a CRO. You have at least 1 year’s experience as Outsourcing Manager, Clinical Trial Manager or equivalent and are looking for a more in-depth understanding of best practices and skill sets in clinical outsourcing to increase your competencies.
You may also work as Clinical Project Manager and have several years of experience, but still look for increased confidence in overseeing your vendors.
What you will learn
- Industry best practices for how to: Plan, qualify and select a CRO for a clinical study, negotiate with a CRO and align expectations with your CRO
- How to perform CRO oversight
- How to manage a CRO, e.g. how to escalate and resolve issues
- Understand the overall principles of the legal part of a CRO agreement and site agreement
- Understand ICH GCP E6 guideline R2 revisions on sponsors, sites, CROs and vendors
What your company will get
- An employee who is be able to implement the revisions to ICH GCP E6 guideline on sponsors, sites, CROs and vendors at your company
Course calendar
DAY 1
- What is Vendor Management?
- Introduction to CRO Business Development
- Introduction to vendor oversight
- Regulatory authorities and requirements
DAY 2
- The Vendor Manager’s role in contract negotiations
- Outsourcing process steps
- Planning phase • Selection phase
DAY 3
- Contract and startup phase
- Maintenance phase
- Closure phase
Registration
Registration deadline24. Jan 2022
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.
Please familiarize yourself with the mandatory readings before starting the course.
Prerequisites
You must have at least 1 year’s experience with CRO collaboration, interaction and/or negotiation, preferably in relation to outsourcing of clinical trials.
Examination
There is no exam for module 1. After module 2, an exam will be held, usually 4-6 weeks after completion of module 2.
The exam is conducted online, and you can therefore take the exam in your own country.
Course leader(s)
WIN Outsourcing Consult
Lecturers
LIFE SCIENCE PLUS Advokater
Y-mAbs Therapeutics A/S
NOVO NORDISK A/S
LEO PHARMA A/S
Vaccibody Denmark A/S
Genmab A/S
Cerba Research
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Want to know more or need help?
Contact Client Manager Christina Spangsberg at +45 39 15 09 22
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