Phases in the evaluation of the occupational exposure to a chemical substance/API. PHASE 1: Risk detection and initial assesment.

The aim of the hazard assessment is to determine the classification and labelling of the substance and to establish the concentration in the air of that substance at which it is considered that approximately almost all workers can be repeatedly exposed (day after day, in a job done throughout their life) without adverse effects; the…

Key factors for the implementation of directive ICH Q3D on elemental impurities

ICH Q3D Guideline is focused to limit the presence of potentially toxic elemental impurities in human medicines. There are 4 issues to be taken into account before starting the risk analysis:   The strategies that we follow will largely depend on the suppliers’ baseline information. The number of products requiring risk analysis, which will also…

RMP changes to GVP Module V- A doorway to better risk-oriented, scientifically valuable RMPs

On 31 March 2017, the EMA released a second revision of Module V- Risk Management Systems of Good Pharmacovigilance Practice (GVP) (EMA/838713/2011 Rev 2), together with a revised Guidance on the format of the risk management plan (RMP) in the EU – in integrated format (EMA/PRAC/613102/2015 Rev 2). During the transition period, RMPs prepared according…

Safety Reports: The importance of high quality content from regulatory perspective

The action plan developed by the AEMPS and published April 2016 focuses on the set up of specific activities, such as the publication of Risk Management Plans Summaries by the agency or the need to increase the number of inspections included in the Good Pharmacovigilance Practice programmes for human and veterinary use. Essentially, this infers…