GCP for Clinical Research Professionals
Online course in English

GCP_Grundlagenkurs_Notghiacademy

Keine Veranstaltungen

We offer this online GCP course also in German language –
GCP Auffrischungs- / Update-Online Kurs

Dr. Notghi Academy is a provider for further education and seminars for the biopharmaceutical industry. For more than 10 years, we have been training and qualifying specialists for this market. We are located in the centre of Berlin, Germany and associated to Dr. Notghi CRO GmbH. Our trainers are experts in their field with long-time experience in the clinical research industry.

The GCP for Clinical Research Professionals online course given in English language facilitates study team members all over the world to join this training.

This GCP course can also be provided individually for your staff team as an in-house seminar. Tailored according to your needs and requirements. Conducted online or live at your location.
Please contact us for an individual quotation!

Aim

This online GCP course is aimed at Clinical Research Professionals working in the biopharmaceutical industry. The training content includes the essential ICH-GCP guidelines and regulations and gives an overview of the planning and conduct of clinical trials. It enables a clear understanding of GCP and the daily business in clinical trials.

Duration: 3 hours
Venue: Virtual live session
Training language: English

Audience

Clinical Research Professionals

  • CRAs, Data Managers, Regulatory Affairs Associates, Medical Writer, Drug Safety Specialists
  • Project Managers
  • Study Nurses, Study Coordinators
  • Investigators and Study Team Members

Training content

  • Principles of Study Design
    • Definitions
    • Interventional and non-interventional studies
  • Ethical Principles
    • Historical background
    • Declaration of Helsinki, Code of Nuremburg
    • ICH-GCP (E6R2)
  • Legal Regulations
    • EU directive 536/2014
    • Directives and regulations outside EU
  • Preparation and Planning
    • Responsibilities & Delegations (Sponsor, Investigator, CRO)
    • Resource planning
    • Patient recruitment
    • Patient Information and Informed Consent
    • Investigational Product Management
  • Conducting Clinical Trials
    • Compliance with the protocol
    • Safety Management, Pharmacovigilance
    • Data Management
    • Monitoring, Audits & Inspections

Certificate

Internationally recognized GCP Certificate in English language.

Attendance Fee

EUR 350.00 (plus VAT 19%)

For more than one registration for the same course date, we offer a discount of 10%.

This course will be delivered in online format from 09.00-12.15 via Zoom.

You will get the dial-in link after registration and the respective certificate after completing the course.

This course can also be provided as an in-house training in German or English language. Please contact us for an individual and tailored quotation.

 

Your registration

For more participants and discounts, please contact us via mail at academy@notghi.com

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