SUMMARY
Module 2
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 is an advanced course that provides you with solid knowledge of industry best practices for clinical outsourcing management. It will also make you feel confident performing high-quality oversight of your selected Vendors, your CRO, and its subcontractors.
It also provides you with a thorough knowledge about how to 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) and Vendor(s).
Among other things, you learn about negotiation techniques, different contractual and pricing models with CROs as well as how to foresee potentials misunderstandings and issues and how to resolve these.
All in all, this will enable you to improve relations with your CRO and Vendors and increase the likelihood of good results.
This course builds on the learning of our basic course in Vendor Management and Oversight.
Keywords
- Clinical outsourcing management
- Clinical vendor management
- Vendor Oversight
- Risk Based Quality Management (RBQM)
- Investigator agreements
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Course leader & lecturers
- Tina HardeCourse leaderSenior Outsourcing Manager
Novo Nordisk A/S - Jan LaustenLecturerCategory Lead
Novo Nordisk A/S - William Andy LawtonLecturerConsultant/Director
Risk Based Approach Ltd - Iben SkovLecturerPrincipal Compliance Specialist
Novo Nordisk A/S - Ulla SteenstrupLecturerDirector, Legal Lead, Clinical Development
Genmab - Christine MartinLecturerPh.d.
CliniSProc
Is this course for you?
This is an extended course for employees in pharmaceutical, biotech, or medico companies whose responsibilities include working with a CRO. You work as e.g. Outsourcing Manager, Clinical Trial Manager, or Clinical Project Manager and want more in-depth knowledge of best practices and a competence boost in clinical outsourcing. You have completed the Basic module or have equivalent experience.
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.
- To understand the financial and legal complexities of CRO and Site agreements.
- How to manage a CRO and perform Oversight, e.g. how to escalate and resolve issues.
- To understand ICH GCP E6 Guideline R2 revisions on sponsors, Sites, CROs, and Vendors.
What your company will get
- An employee who is confident in the outsourcing process and can select the right CRO for a study.
- An employee who knows how to align expectations and scope the outsourced activities correctly.
- An employee who can follow up on CRO deliverables and perform high quality oversight and risk management.
- An employee who can use the best negotiation technique as well as the best financial set-up and payment structure.
- An employee who can resolve issues and conflicts with CROs.
- An employee who understands the legal contract with CRO and Site.
Course calendar
Day 1
- Risk Management
- Vendor performance management
- Vendor Relationship management
- Vendor Oversight
Day 2
- The CRO Master Service Agreement and Site Agreements
- GDPR and Compliance
- Financial considerations and understanding required by a Vendor Manager
Day 3
- Financial consideration and understanding required by a Vendor Manager (continued)
- Negotiation skills, tactics and strategies
- Negotiation during a conflict
Registration
Registration deadline13 Nov 2023
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course you get access to optional readings via your personal Atrium log-in. Please familiarise yourself with the 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.
In order to gain the full benefits from the course, you should have knowledge equivalent to that acquired at our basic course in Vendor Management and Oversight.
Course leader
Novo Nordisk A/S
Lecturers
Novo Nordisk A/S
Risk Based Approach Ltd
Novo Nordisk A/S
Genmab
CliniSProc
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