Summary
Are you compliant with the ICH GCP E6 Guideline R2 revisions on sponsors, Sites, Contract Research Organisations (CROs) and Vendors? And are you confident in your interaction and negotiation with these?
This three day course provides you with basic knowledge about how to comply with ICH GCP E6 Guideline R2.
You also gain insights into 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 potentials misunderstandings and issues. This will enable you to improve relations with vendors and ensure good results.
Please note: We also offer an advanced course in Vendor Management and Oversight.
Keywords
- Clinical outsourcing management
- Vendor oversight
- Risk management
- Legal contracts
- Compliance
- Investigator agreements
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Course leader & lecturers
- Tina HardeCourse leaderSenior Outsourcing Manager
Novo Nordisk A/S - Joy BladhLecturerFounder & CEO
Yoj ApS - Désirée HammerstadLecturerDirector of Outsourcing Management
Nykode Therapeutics Denmark A/S - Gertrud Koefoed RasmussenLecturerVP, Head of Development Operations
Nykode Therapeutics ASA - Camilla WalkerLecturerPrincipal Partnership & Vendor Manger
ALK-Abelló A/S - Anders TrojelLecturerBusiness Development Director
Syneos Health Denmark ApS - Jacqui GatehouseLecturerFounder
GATEHOUSE THIRTEEN - Anne Søltoft AndersenLecturerOutsourcing Manager
Novo Nordisk A/S
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Is this course for you?
This is a basic course for employees in pharmaceutical, biotech, or medico companies whose responsibilities include working with a CRO. It is an advantage to have some experience in the field. You work as e.g. Outsourcing Manager, Clinical Trial Manager, or Clinical Project Manager and want in-depth knowledge of best practices and a competence boost in clinical outsourcing.
What you will learn
- Industry best practices for how to plan, qualify, and select a CRO for a clinical study.
- How to negotiate and align expectation with a CRO.
- How to carry out oversight and manage a CRO, e.g. how to solve problems.
- 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 understands the overall principles of the legal part of a CRO agreement and site agreement.
- An employee who understands ICH GCP E6 guideline R2 revisions on sponsors, sites, CROs, and vendors.
- An employee with insights into implementing the revisions to ICH GCP E6 guideline in your organisation.
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 deadline29 Nov 2024
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Optional readings will be available via your personal Atrium log-in. Please familiarise yourself with the readings before starting the course.
Prerequisites
You must have some experience with CRO collaboration, interaction and/or negotiation, preferably in relation to outsourcing of clinical trials.
Course leader
Novo Nordisk A/S
Lecturers
Yoj ApS
Nykode Therapeutics Denmark A/S
Nykode Therapeutics ASA
ALK-Abelló A/S
Syneos Health Denmark ApS
GATEHOUSE THIRTEEN
Novo Nordisk A/S
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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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