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Regulatory Roadmap for the development of human medicinal Products (Europe focus)

Just click on the various stages below to reveal the information.


First in Man/Clinical Trials

DESCRIPTION

Phase I or First in Man/Clinical Trials - when an investigational medicinal product (IMP) developed and assessed through in-vitro or animal testing, is tested on human subjects for the first time.

Marketed products may fall under the same regulations if the product is used as part of an interventional trial. (The product must meet the definition of an IMP).

INPUTS

Test Article Safety Reports (GMP)
Pre- clinical Data (GLP)

PROCESSES

GCP : Clinical Research (Phases 1)
GCP & GPVP: Pharmacovigilance
GMP : IMP Manufacturing

REGULATIONS

GCP : Clinical Research (Phase 1)

GCP & GPVP : Pharmacovigilance

GMP : IMP Manufacturing

GUIDANCE

GCP : Clinical Research (Phases 1)

GCP & GPVP : Pharmacovigilance

GMP: IMP Manufacturing

GDP

Computer Systems Validation

OUTPUTS
  • Clinical Study Reports (CSR)
  • Data to support the creation of the Common Technical Document for submission for marketing application
  • Trial Master File (TMP)
RQA Courses/Seminars/eLearning

 Professional Development Courses and Seminars

 eLearning

RQA Publications

 Roles & Responsibilities of GLP Management

 Hosting an External GLP Inspection

 A Practical Guide to GLP Quality Assurance

 Good Clinical Laboratory Practice (GCLP)

 Good Clinical Practice Regulatory Authority Inspections

 The Role of the Monitor in Veterinary Clinical Studies