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CPM - Clinical Project Management

Opleiding

General and specific clinical trial project management aspects are discussed during two consecutive days. You will see how to manage clinical trials: understanding elements and phases of a clinical trial, setting specific goals and measures, defining and managing resource needs (staff and budget), performing risk management, collaboration with other internal and external organizations, learn how the clinical trial program fits into the general scope of the company…

Aside from the general project related aspects, clinical trial related aspects are considered at every stage of the course: the regulations (ICH-GCP, Medical Device Directive), ethical aspects, hospital environment, working with CROs, the quality system and related standard operating procedures, contract management, audits and inspections, monitoring, clinical data quality, reporting expectations, closing of a project.

Practical exercises allow to test the learned aspects. The specific clinical trial orientation of the course allows you to implement the learned elements immediately in Your daily activities.

Praktisch

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Prijs

LEDEN € 1.100
NIET-LEDEN € 1.265

KMO-portefeuille: vraag hier uw subsidie aan en bespaar tot 40% op uw inschrijvingsprijs.
Erkenningsnummer Allanta: DV.O105117

 

Word lid

Uw opleiding in detail

Agendapunten

2-day training:

Fundamentals of (clinical trial) projects
Roles and responsibilities of the project manager, CRA, CTA
Clinical trial environment (hospital, regulations, SOPs)
Investigators, ethics committees, DSMB, pharmaco-vigilance…
Planning of a trial, implementation and execution of the project from A to Z
Dealing with obstacles
Managing the quality and managing expectations
Managing the resources (staff and budget)
Project improvement: performance assessment and management (PDCA)
Good communication skills
Reporting and project management tools: waterfall & Gantt chart
Keys to a successful clinical trial
Continuous learning


Uw
certificaat

All students who attend 75% of classes, will receive a certificate of participation.


Annulatie

Annuleren is alleen schriftelijk mogelijk. Bij annulering méér dan 3 weken voor aanvang van cursus is 75,00 EUR administratiekost verschuldigd. Daarna is 100% van de deelnameprijs verschuldigd. Vervanging van de ingeschrevene is steeds mogelijk, mits melding aan ons secretariaat. Door onvoorziene omstandigheden kan Allanta vzw genoodzaakt zijn de opleiding te annuleren, het programma, de datum of de locatie te wijzigen.


Uw Contact-
persoon

Nele Gregoor

TEL +32 (0) 11 870 944

info@allanta.be





Daniel
Sanchez
GSK


Medical GSK</br> </br> </br>

"The training was very well organized, the facilities and environment were quite good. I especially liked the format of 6 modules x 3 days, it allows an...

ALLE REFERENTIES
deelnemer
Materialise
Materialise


Medical Materialise</br> </br> </br>

Hands-on, focus on detail, lots of extra input was given when asked for! Thank you!!  There were numerous posibilities to have discussions on certain topi...

ALLE REFERENTIES
Sandra
Stam
Regus Surgical


Medical Regus Surgical</br></br></br>

Er werd een breed en gevarieerd programma aangeboden. Het publiek was divers, maar er waren zeker en vast interessante topics of cases voor elk individu.

ALLE REFERENTIES
Laurel
Berzanskis
Materialise


Medical Materialise</br> </br> </br>

  I really liked the practical tips for doing an internal audit. Often, people overlook the value of learning the soft skills.

ALLE REFERENTIES