considerations for effective pharmacovigilance and EU regulation

An RMP for a biosimilar must consider the risks observed during the use of the reference product as well as potential risks. It has also to indicate how to ...

The development of biosimilars is growing rapidly, especially in Europe. They are a cost-effective alternative to original biological ...

considerations for effective pharmacovigilance and EU regulation

The risk management plan for biopharmaceuticals (innovator and biosimilar drugs) should be based on strengthening ongoing pharmacovigilance ...

Implementation of the pharmacovigilance legislation

The pharmacovigilance legislation, which came into effect in 2012, introduced a range of tasks and streamlined existing responsibilities for regulators and the ...

Guideline on good pharmacovigilance practices (GVP) Module I

Commission Implementing Regulation (EU) No 520/2012 on the Performance of Pharmacovigilance. Activities Provided for in Regulation (EC) No ...

The EU's complex safety reporting landscape - PharmaLex

Specific legislative requirements on pharmacovigilance (PV) are addressed in the legislation that came into effect in 20123 and in EU Good ...

Effective Pharmacovigilance System Development: EFPIA-IPVG ...

This framework requires national regulatory authorities (NRAs) to establish and maintain a pharmacovigilance system (PV system) stating and ...

EU's New Pharmacovigilance Legislation: Considerations for ...

Recently, new European Pharmacovigilance legislation has been implemented, ensuring proper risk management through the recording of suspected adverse drug ...

Guideline on good pharmacovigilance practices (GVP): product or ...

... considerations i: vaccines for prophylaxis against ... Where EU guidelines adopted in Australia include references to EU legislation ...

Evaluating the Effectiveness of additional Risk Minimisation ...

New EU pharmacovigilance legislation, effective in 2012,3 added an explicit requirement to ... This section focuses on recruitment considerations and challenges ...

Current state of biologic pharmacovigilance in the European Union

In good pharmacovigilance practices guidelines, the EMA distinguishes biologics from chemically synthesized medicines, noting their complexity ...

The STAR Compass to Guide Future Pharmacovigilance Based on a ...

To deliver this vision, four principles are proposed to guide actions for further progressing the EU pharmacovigilance system: synergistic ...

6.2 Key pharmacovigilance regulations in the EU - Oxford Academic

The key pharmacovigilance legislation is Regulation (EU) No. 1235/2010 (amending, as regards pharmacovigilance of medicinal products for human use, Regulation ( ...

Current state of biologic pharmacovigilance in the European Union

2010 EU pharmacovigilance legislation on ... The surge in biosimi- lars: considerations for effective pharmacovigilance and EU regulation.

National Differences in Pharmacovigilance Requirements in Europe

Pharmacovigilance requirements in Europe are primarily governed by the European Medicines Agency (EMA) through the EU Regulation on Pharmacovigilance ...

Revisiting EU Pharmacovigilance Legislation | Freyr

Transparency and effective communication are vital for maintaining public trust in the pharmacovigilance system. The new legislation requires ...

Pharmacovigilance - World Health Organization (WHO)

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/ ...

Guidelines on good pharmacovigilance practices (GVP)

New legislation for pharmacovigilance applies in the European Union (EU) since July 2012, and to support its implementation, a set of guidelines for the ...

Shaping EU medicines regulation in the post COVID-19 era

The EMRN is the cornerstone of medicines' approval and supervision in the EU. The European Union (EU)-wide centralised authorisation procedure, managed by EMA, ...

Ethical considerations in the regulation and use of herbal medicines ...

Difficulties also exist, however, in the pharmacovigilance of conventional medicines. The effectiveness of post-marketing surveillance for conventional ...