Diploma in Vendor Management and oversight (module 1)

Obtain knowledge of best industry practices for clinical vendor management (module 1 of 2)

24. Jan 2022

3 days course

English

17,350 DKK ex VAT
(app. 2,333 EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

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

Hi! Do you need help choosing the right course?

We are ready to help you at +45 39 27 60 60 or contact@atriumcph.com

Read more

Course leader(s) & Lecturers

  • Rikke Winther
    Course leader
    Owner
    WIN Outsourcing Consult
  • Claudia Blomgren-Hansen
    Lecturer
    Owner
    LIFE SCIENCE PLUS Advokater
  • Desiree Hammerstad
    Lecturer
    Senior CRO & Planning Manager
    Y-mAbs Therapeutics A/S
  • Pia Sauer Larsen
    Lecturer
    Snr. Outsourcing Manager
    NOVO NORDISK A/S
  • Andrea Beltrán Olesen
    Lecturer
    Senior Manager Head of Clinical Partnership Management.
    LEO PHARMA A/S
  • Gertrud Koefoed Rasmussen
    Lecturer
    Head of Clinical Operations
    Vaccibody Denmark A/S
  • Kristine Dalsgaard Cohen
    Lecturer
    Assistant Director R & D Contract Management
    Genmab A/S
  • Anders Beltoft
    Lecturer
    Sr. Director Business Development
    Cerba Research
See all

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

  1. 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
  2. How to perform CRO oversight
  3. How to manage a CRO, e.g. how to escalate and resolve issues
  4. Understand the overall principles of the legal part of a CRO agreement and site agreement
  5. Understand ICH GCP E6 guideline R2 revisions on sponsors, sites, CROs and vendors

What your company will get

  1. 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

Starting 24. Jan 2022
24. Jan 2022 8:30-17:15

DAY 1

  • What is Vendor Management?
  • Introduction to CRO Business Development
  • Introduction to vendor oversight
  • Regulatory authorities and requirements
25. Jan 2022 8:00-17:00

DAY 2

  • The Vendor Manager’s role in contract negotiations
  • Outsourcing process steps
  • Planning phase • Selection phase
26. Jan 2022 8:00-16:15

DAY 3

  • Contract and startup phase
  • Maintenance phase
  • Closure phase
Practical information

Registration

Registration deadline
24. Jan 2022
Atrium
Lersø Parkallé 101
2100 København Ø
Sometimes things change. This is the expected programme.

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)

Rikke Winther
Owner
WIN Outsourcing Consult

Lecturers

Claudia Blomgren-Hansen
Owner
LIFE SCIENCE PLUS Advokater
Desiree Hammerstad
Senior CRO & Planning Manager
Y-mAbs Therapeutics A/S
Pia Sauer Larsen
Snr. Outsourcing Manager
NOVO NORDISK A/S
Andrea Beltrán Olesen
Senior Manager Head of Clinical Partnership Management.
LEO PHARMA A/S
Gertrud Koefoed Rasmussen
Head of Clinical Operations
Vaccibody Denmark A/S
Kristine Dalsgaard Cohen
Assistant Director R & D Contract Management
Genmab A/S
Anders Beltoft
Sr. Director Business Development
Cerba Research

You may also be interested in these courses

Want to know more or need help?

Contact Client Manager Christina Spangsberg at +45 39 15 09 22

Send me a message