Pre Licensing Activities

• Phase II-IIIa research covers subsequent clinical trials conducted prior to a marketing licence application and is designed to gather further data in relation to safety and efficacy to be used as part of the submission. 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 investigational medicinal product -IMP.)
• Company Core Safety Information finalised and benefit-risk confirmed.
• Prepare marketing authorisation application (MAA)/new drug application(NDA) dossier.
• The process for gathering data contained in the clinical safety and efficacy section of the common technical document (ICH M4E) and establishing the processes which formulate the Quality and Chemistry and Manufacturing Controls section of the common technical document (ICH M4Q).

Clinical Study Reports
Trial Master File
Data to support the Dossier (Chemistry Manufacturing Control (CMC))
Test Article Safety Reports

GCP : Clinical Research (Phases II-IIIa)
GCP & GPVP : Pharmacovigilance
GMP : IMP Manufacturing
GMP : Test Article Manufacturing

MAA Application

• http://ec.europa.eu

GCP : Clinical Research (Phases II-IIIa)

• 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

Clinical Trials Directive 2001/20/EC

GMP : IMP Manufacturing

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

MAA Application

• Volume 2A dealing with procedures for marketing authorisation
• Volume 2B dealing with the presentation and format of the application dossier
• Volume 2C dealing with regulatory guidelines

Common Technical Documents

• ICH M4
• ICH M4E
• ICH M4
• ICH M4S

Pre-submission Meeting Guidance

• http://www.ema.europa.eu/ (PDF)

GCP : Clinical Research (Phases II-IIIa)

• 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)
• Link to GMP Q&A MHRA

GDP

• http://www.mhra.gov.uk/
• MHRA UK Guidance Notes

Computer Systems Validation

• GAMP5
• FDA Guidelines for Computer Systems Validation

Common Technical Document (CTD)
Prepare MAA/NDA dossier
Licensed/Compliant Manufacturing Facility
Finalise Company Core re Safety information, prepare regions prescribing information
Propose Clinical Phase IIIb and IV plans
Develop Life Cycle Management plans
Benefit-risk confirmed
Patient Risk Management Plan implemented 

 Professional Development Courses and Seminars

 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