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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.


Variations to Licence

DESCRIPTION

Maximised potential/contribution of compound
New indications
Patent extensions
Paediatric studies
Orphan drug status

INPUTS

Product Licence
Submission of change request
Life cycle management
Ongoing surveillance
Signal detection
Updates to Company Core Safety Information

PROCESSES

GMP : Product Manufacturing
GMP : Distribution
GCP, GMP & GPVP : Post Marketing Studies
GCP & GPVP : Pharmacovigilance

REGULATIONS

Control of Substances Hazardous to Health (COSHH)
UK Medicines Act 1968
Commission Regulation  EC/2141/96 regarding transfer of a marketing authorization
Commission Regulation  EC/1084/2003 regarding variations
Commission Regulation  EC/1085/2003 regarding variations
Commission Regulation EC/1234/2008 regarding variations
Commission Directive 2009/53/EC (amending Directive 2001/82/EC and 2001/83/EC) regarding variations to marketing authorisations

Product Manufacturing

Distribution

Pharmacovigilance

Good Clinical Practice

Review of Various Regulations- Major Developments

GUIDANCE

Volume 9A of the Rules Governing Medicinal Products in the EU
MHRA The Good Pharmacovigilance Practice Guide(Purple Guide) publication
Eudralex Volume 2 Pharmaceutical Legislation Notice to Applicants and Regulatory Guidelines Medicinal Products for Human Use
Eudralex Volume 10 Clinical trial guidelines:

Computer Systems Validation

OUTPUTS Updated product licence
Change process(es)
Maintain support to health authorities, routine compliance activities
Maximised potential/contribution of compund
 
RQA Courses/Seminars/eLearning

 Professional Development Courses and Seminars

 eLearning

RQA Publications

Good Clinical Laboratory Practice (GCLP)

Good Clinical Practice Regulatory Authority Inspections

The Role of the Monitor in Veterinary Clinical Studies

 Pharmacovigilance Auditing

 Pharmacovigilance Inspection Guidance