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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.


Pre Licensing Activities

DESCRIPTION
  • 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).
INPUTS

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

PROCESSES

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

REGULATIONS

MAA Application

GCP : Clinical Research (Phases II-IIIa)

GCP & GPVP : Pharmacovigilance

Clinical Trials Directive 2001/20/EC

GMP : IMP Manufacturing

GUIDANCE

MAA Application

Common Technical Documents

Pre-submission Meeting Guidance

GCP : Clinical Research (Phases II-IIIa)

GCP & GPVP : Pharmacovigilance

GMP: IMP Manufacturing

GDP

Computer Systems Validation

OUTPUTS

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 

BARQA Courses/Seminars/eLearning

 Professional Development Courses and Seminars

 

BARQA 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