First in Man/Clinical Trials

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).

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

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

GCP : Clinical Research (Phase 1)

• Clinical Trial UK Legislation
  • Statutory Instrument 1031
  • Statutory Instrument 1928
  • Statutory Instrument 2984
  • Statutory Instrument 941

• Clinical Research EU Directives
  • Clinical Trials Directive 2001/20/EC
  • Commission Directive 2005/28/EC
  • Commission Directive 2003/94/EC

GCP & GPVP : Pharmacovigilance

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  • Clinical Trials Directive 2001/20/EC

GMP : IMP Manufacturing

• GMP Directive
• Annex 13 (PDF)
• MHRA Orange Guide

GCP : Clinical Research (Phases 1)

• ICH E6 Good Clinical Practice
• ABPI phase 1 guidance
• Medicines for human use Eudralex
• Clinical Trials Toolkit
• Serious Breaches Guidance

GCP & GPVP : Pharmacovigilance

• Volume 10 Entry CT3
• Volume 10 Entry CT4
• PV -Volume 10 Entry CT2
• MHRA Good Pharmacovigilance Practice Guide (Purple Guide) publication

GMP: IMP Manufacturing

• Eudralex Volume 4 (GMP)

GDP

• MHRA

Computer Systems Validation

• GAMP5
• FDA Guidelines for Computer Systems Validation

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

 Professional Development Courses and Seminars

 eLearning

 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