In this e-learning you will get valuable, state-of-the-art information on the interpretation and implementation of the Good Clinical Practice in your clinical investigations with medical devices.

T00044

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Rianne Tooten

Trainer
+31(0)35 - 543 00 21

Module 1: Scope

Module 2: Ethical Considerations

Module 3: Clinical Investigation Planning

Module 4: Clinical Investigation Conduct

Module 5: Clinical Investigation Close Out

Module 6: Sponsor Responsibilities

Module 7: Principal Investigator Responsibilities

Online modules & personal online meeting on request

You learn how to:

  • add credibility to your clinical data
  • protect your subjects rights & safety
  • worldwide acceptance of your data
  • no more findings during inspections
  • avoid unnecessary risk for patients
  • avoid unnecessary regulatory delay
  • implement the regulation
  • including practical solutions

Facts

Doelgroep:Clinical Research Professionals active in



- active implants

- anaesthetic and respiratory devices

- biomaterials

- coatings

- dental devices

- delivery devices

- diagnostic and therapeutic radiation devices

- diagnostic devices

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- reusable devices

- electromechanical devices

- medical software and record

- single use devices
Duur:5,5 hours including the exam
Vorm:Online training & personal support from trainer
Tijd:non applicable
Locatie:Online
Lunch / diner:N/A
Competenties:
Kosten:€ 450,00 including the exam

Mrs. Rianne Tooten

Clinical trial specialist for sponsored as well as investigator initiated clinical trials. Medical device expert at METC UMCG.

Over 13 years documented allround CRA experience (CRO and Sponsor):
Involved in national and international projects for international Sponsors. Experience in medical devices, foods for special medical purposes (FSMP) and baby food as well as pharmaceuticals.

8 years of documented experience in study management of several studies (NL, European, US; Sponsored and Investigator Initiated) in FSMP and medical devices.

Medical Device consultant for training on the MDR, ICH-GCP and ISO14155 and implementation.

Experience in the following therapeutic areas:
– orthopedics & cardiology & dentistry (medical devices)
– diabetes & Dysplastic Colorectal Cancer (pharma & Medical devices)
– IBD (Pharma)
– Alzheimer’s disease (FSMP)
– Regurgitation (baby food)

Specialties:
– Helicopter view as well as detail oriented
– Stakeholder engagement
– Presenting
– Providing training
– Networking
– Inspiring + motivating others
– Quality
– People person

Member of NVFG, DCRFN

  • Nog geen data bekend

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