Center for Professional Innovation & Education, Inc., Berlin, Germany
Mar. 17 – 19, 2014
This three-day GCP training course is designed to provide individuals with an in-depth understanding of the clinical research process, the roles and responsibilities of key players, as well as, regulatory requirements. The course consists of lecture and exercises designed to focus on the practical implementation of the GCP requirements. Participants will also be placed in several real life situations such as reviewing pre-study documents and informed consent form for completeness and compliance; conducting drug accountability; reviewing case report form for accuracy and adherence to protocol and performing source document verification. The GCP training course will also provide the attendee with thorough knowledge of the following topics: - How drugs are discovered and developed for marketing approval
- The four different study phases of clinical research
- What constitutes Good Clinical Practices (GCP)
- Regulatory updates
- How the requirements differ in the US, EU, India, China & Japan
- The principles of ICH GCP
- The IRB/IEC’s composition and role/responsibilities
- The IRB study review & approval process
- The role and responsibilities of the investigator & study site staff
- The role and responsibility of the sponsor
- The history of the FDA & EMA and their role & responsibilities
- Which sections of 21 CFR and ICH Guidelines govern conduct of clinical studies
- The purpose for an IND / CTA and its composition
- How INDs & CTAs are filed, reviewed, approved & amended
- The IND/CTA reporting requirements
- The requirements for Informed Consent
- How to review an Informed Consent form for compliance
- The process for Informed Consent review & approval
- The administration of subjects Informed Consent
- The different types of study Monitoring visits & tasks for each
- Adverse Events - the types and reporting requirements
- How to perform Drug Accountability & compliance
- How to manage study supplies
- How to detect and deal with Fraud
- The purpose and composition of the NDA/MAA
- How NDAs/MAAs are filed, reviewed and approved
- Sponsor responsibilities after approval
- How to review study documents & determine compliance
- How to review Case Report Forms and determine adherence to protocol
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
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