The European Clinical Trial Regulation 536/2014 - A Clear Outline

Tijdsduur
Startdatum en plaats
Logo van European Centre for Clinical Research Training

Tip: meer info over het programma, startdatum, prijs, en inschrijven? Download de brochure!

Startdata en plaatsen

Webinar
14 okt. 2019

Beschrijving

The European Clinical Trial Regulation 536/2014 - A Clear Outline

Course Description

For this 1.5 hours interactive webinar, we apply the “less is more” principle with schematic presentations helping you to get a crystal clear view of the changing legislative landscape in order to prepare you and your organisation for a smooth transition. The regulation will have no more surprises to you.
You will learn about scope, definitions, application and validation processes, mandatory notifications, rules for safety reporting, timelines and time table for implementation of the European Clinical Trial Regulation 536/2014. This webinar is your “rough guide” to grasp the main rules prior to its implement…

Lees de volledige beschrijving

Veelgestelde vragen

Heb je een vraag? Onze adviseurs helpen je graag. Stuur een e-mail naar help+flanders@springest.be

Nog niet gevonden wat je zocht? Bekijk deze onderwerpen: Assessment, Organiseren, Coach / Coaching, ICT Management & Strategie en Integraal management.

The European Clinical Trial Regulation 536/2014 - A Clear Outline

Course Description

For this 1.5 hours interactive webinar, we apply the “less is more” principle with schematic presentations helping you to get a crystal clear view of the changing legislative landscape in order to prepare you and your organisation for a smooth transition. The regulation will have no more surprises to you.
You will learn about scope, definitions, application and validation processes, mandatory notifications, rules for safety reporting, timelines and time table for implementation of the European Clinical Trial Regulation 536/2014. This webinar is your “rough guide” to grasp the main rules prior to its implementation. In addition, you will have the opportunity to ask questions during and after the session. The session ends with an extensive Q&A round. 
The webinar will allow participants to attend from all over the world, without any travel requirements.

Learning objectives

  • Grasp the main processes and requirements of the European Clinical Trial Regulation 536/2014.
  • Understand what is needed to come to implementation of the Regulation

Programme highlights

  •  Framework of the current and future European Clinical Trial Legislation
  •  The European Clinical Trial Regulation 536/2014:

 - New definitions

 - Scope

 - Clinical Trial Application Process

 - Mandatory Notifications

 - Safety Reporting

 - Time Table for Implementation

Workshops

• Application forms for EC and authorities in practice
• How to process SUSARs

Who should attend

Everyone involved in clinical research including: pharmaceutical companies, CROs, investigators, site personnel and ethics
committee members.
People from clinical research, regulatory affairs and pharmacovigilance departments within the pharmaceutical industry.

*Due to unforeseen circumstances, the programme may change and the ECCRT reserves the right to alter the venue or cancel the event.

Trainer: Marleen Verbeeck, PhD & Gerald Van Roey

Language: English

Important: In case you have more than 5 interested participants you can save about 50% of your costs by inviting the trainer over for a tailored on-site training

Blijf op de hoogte van nieuwe ervaringen

Er zijn nog geen ervaringen.

Deel je ervaring

Heb je ervaring met deze cursus? Deel je ervaring en help anderen kiezen. Als dank voor de moeite doneert Springest € 1,- aan Stichting Edukans.

Heb je een vraag? Onze adviseurs helpen je graag. Stuur een e-mail naar help+flanders@springest.be

Vraag nu gratis en vrijblijvend informatie aan:

Aanhef
(optioneel)
(optioneel)
(optioneel)
(optioneel)
(optioneel)
(optioneel)
(optioneel)
We slaan je gegevens op, en delen ze met European Centre for Clinical Research Training, om je via e-mail en evt. telefoon verder te helpen. Meer info vind je in ons privacybeleid.