Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

GVP module V revision 2 a review of recommendations and main changes

Dr. Maxim Frizler (Abschlußjahr: 2018)

Summary
Language: English
With the new pharmacovigilance legislation in the EU laid down in Directive 2010/84/EU and Regulation (EU) No 1235/2010 amending the legal acts of the Union – Directive 2001/83/EC and Regulation (EC) No 726/2004, all applicants are required to submit a risk management plan (RMP) at the time of the initial marketing authorisation application irrespective of the route or type of authorisation.
With the new legislation for pharmacovigilance, a set of guidelines for the conduct of pharmacovigilance, the rules of good pharmacovigilance practices (GVP), has been developed. The detailed guideline on the RMP is laid down in GVP module V – risk management systems.
On 31 March 2017, the revision 2 of GVP module V came into effect, which will finally replace the revision 1 of GVP module V by the end of the transition period on 31 March 2018.
The primary aim of the revision of GVP module V was the establishing of a guidance that would support the creation of risk proportionate and functional RMPs in which specific measures for the minimisation and further characterisation of identified safety concerns are laid down. The definition of a safety concern to be addressed in the RMP has been substantially revised for that reason. In addition, there is a number of further amendments throughout GVP module V to remove the recommendations of including redundant information within the RMP or information to be provided in other parts of eCTD. The RMP template has been revised accordingly.
This master thesis represents a systematic review of recommendations of GVP module (Rev 2). The main changes to the previous guidance, i.e. GVP module (Rev 1), are discussed in detail to highlight all important similarities and differences. The corresponding changes to the guidance on format are addressed in parallel by a direct comparison of RMP template (Rev 2) with RMP template (Rev 1).
There is no doubt that GVP module V (Rev 2) provides a more precise guidance that contains a detailed explanation of what an RMP should focus on. A number of unnecessary recommendations have been removed. However, some parts of GVP module V still require further clarification. This especially concerns the definition of a safety concern in GVP Module V (Rev 2) that still leaves some room for interpretation. All controversy points are addressed in the master thesis.
The master thesis may provide a support for all stakeholders involved in the risk management in the EU during the switch to the new guidance on the RMP. In addition, a historical perspective of the development of the guidance on the RMP is provided with this master thesis.
Pages: 43