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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 MHRA Orange Guide Distribution MHRA Good Distribution practice Pharmacovigilance Regulation EC/726/2004 Commission Regulation EC No 540/95 regarding suspected adverse reactions which are not serious Commission Directive 2001/83/EC (as amended) Guideline on the definition of a potential serious risk to public health 2006/C 133/05 Good Clinical Practice Directive 2001/20/EC Commission Directive 2003/94/EC Commission Directive 2005/28/EC 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 GAMP5 - FDA Guidelines for 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