Print Page   |   Contact Us   |   Sign In   |   Join
GCP - Understanding and Implementing the Current Global Requirements
Tell a Friend About This EventTell a Friend
 

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.

4/29/2015 to 5/1/2015
When: April 29-May 1, 2015
Where: Desmond Hotel and Conference Center
Malvern, Pennsylvania 
United States
Presenter: The Center for Professional Innovation and Innovation
Contact: 855.752.9320

« Go to Upcoming Event List  

 

  

 

Good Clinical Practices (GCP) – Understanding and Implementing the Current Global Requirements

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

 

Learn more about the course and register.

 

CfPIE is a preferred provider and offers MichBio members a 15% discount on course registration fees. Click here for more information.

Creating Value
by delivering business-critical resources & bottom line savings
Building Networks
by connecting Michigan's bio-industry one member at a time
Growing Talent
by creating opportunities that develop people & build organizations
Membership Software Powered by YourMembership  ::  Legal