PHARMATRAIN News Contact

King's College London

Drug Regulatory Affairs

Practical Information

Commencing Date:
tba
Language:
English
Location:
London United Kingdom


Teaching Methodology:
Face-to-Face
Credits :
Short courses (CPD): 15 CATS


European Fees:
1550 GBP
Non European Fees:
2450 GBP
Scholarship Possibilities:
No

Course Contact

Programme Officer

+44 (0)20 7848 4684

pharm-med@kcl.ac.uk


Website

Fees Information

Office Link

King's College London

University Accreditation: Yes

Centre of Excellence

Description

This module explores the principles that underpin drug regulation in the UK and worldwide. Over four days, we will consider the regulatory requirements for special patient populations, commercial issues from product life cycle development through to marketing, pharmacovigilance, and the handling of off label and unlicensed medicines. Key topics include: European regulatory procedures, ethics committees, adverse drug reaction reporting, regulatory requirements in special populations (eg, children, the elderly), advertising, internet sales, medical aspects of the Marketing Authorisation, bioequivalence and generics, special licensing issues (such as for biologicals, devices, herbal and homoeopathic medicines), and pharmacovigilance (pre- and post-marketing) You will take part in a series of workshops to learn about practical aspects of Clinical Trial Authorisations, preparation of Summaries of Product Characteristics and Patient information leaflets, risk minimisation, and reclassification of the legal status of medicines.

IMI Standards

  • A predefined set of teaching objectives, leading to defined learning outcomes
  • Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
  • A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
  • Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
  • Defined and transparent admission criteria
  • Quality assurance of teaching staff
  • Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
  • The facilities, infrastructure, leadership and competences available for the support of student learning
  • University accreditation OR a system for approving, monitoring and reviewing the training offered