Grossesse et allaitement

Finalisation of GVP P. III on ‘Product– or population–specific considerations: pregnancy and breastfeeding’ post–public consultation.

Révision des Bonnes pratiques de Pharmacovigilance 

• Initiate the public consultation of revision 3 of GVP module XVI on ‘Risk minimisation measures: selection of tools and effectiveness indicators’ with addendum II on ‘Risk minimisation measures effectiveness evaluation
• Finalise revision 3 of GVP module XVI and addendum II post–public consultation, subject to COVID– related work as a priority.
• Finalise GVP module XVI addendum III on ‘Pregnancy prevention programme’ in view of initiating a public consultation.

Evaluation des plans de gestion des risques 

• Contribute to further optimise close cooperation with CHMP and CAT as regards RMP assessments,including RMPs for generic medicinal products and RMP requirements for ATMPs.

Suivi des effets indésirables spécifiques : utilité des questionnaires 

• Consolidate the review on the use and utility of specific adverse reaction follow–up questionnaires as a routine pharmacovigilance activity.

Le PRAC précise « Data and information from the real–world use of medicines is a key enabler for access to new treatments and will support the PRIME scheme and Adaptive Pathway initiatives »

Registres patients – Analyse des données 

• Provide expert input in the implementation of the recommendations from the HMA/EMA Big Data Steering Group.

• Provide expert input to the EMA initiative on patient registries and the cross–Committee task force on registries on the development of guidance on methodological aspects and governance of patient registries: input in the review of the guideline on registry–based studies post public consultation.

• Review of experience gained within the pilot of rapid data analysis: build a checklist based on the experience from actual cases with possible and non–possible data analyses, summarising experience and feedback obtained (including feedback from questionnaire).

Améliorer la gestion des signaux 

Provide expert input in improving methods and outputs including data analytics and retrieval to ensure continuous improvement of signal management, including piloting the algorithm for detecting unexpected increases in frequency of ADR reporting, and machine learning based on EudraVigilance data. This includes methodologies for COVID–19 safety monitoring and input in methodologies to be used during the vaccination campaign.

Impact des interventions règlementaires 

• Provide expert input and scientific guidance for industry and regulators on impact research objectives and methodologies, including training to assessors (related to GVP module XVI, see  under 1.1.2. ).
• Oversee and advise on the conduct of impact research of pharmacovigilance regulatory interventions, including prioritisation of research topics.
• Enhance engagement of patients and HCPs in measuring the impact of regulatory interventions