Two new GVP modules were published in December 2012, Module III – Pharmacovigilance Inspections and Module IV – Pharmacovigilance Audits,  bringing the total of final modules to nine.  It is expected that the remaining modules will be finalised and published in 2013.

The updated annex on GVP definitions was also published.

Module III- Pharmacovigilance Inspections – Member State competent authorities (CAs) must conduct pharmacovigilance (PV) inspections of marketing authorisation holders (MAH) and associated organisations to determine their compliance with EU PV obligations.  The inspectors will be appointed by the national CA and they are empowered to inspect premises, records, documents and the Pharmacovigilance System Master File (PSMF) of the MAH or associated organisation.  The inspectors will determine that the MAH has the personnel, systems and facilities to meet their PV obligations and to identify, record and address non-compliances that may pose a risk to public health.  For non-centrally authorised products, the inspection should ensure that the legal requirements governing medicinal products are complied with.  The inspections will consist of a risk based approach, and “for cause” inspections triggered by suspected non-compliance or potential risks.   Sharing of information and communication between inspectors and assessors from PRAC and CHMP are key to ensuring the proper follow-up of inspections and actions to be taken.   Where appropriate, the Member State concerned should ensure that a MAH is subject to effective, proportionate and dissuasive penalties for non-compliances.

Module IV – Pharmacovigilance Audits – this describes the legislative basis for the minimum requirements of the PV systems, quality system and the scope of risk-based audits for the Member State CAs, the EMA and the MAH.  Guidance on planning and conducting legally required audits is provided.  These align with internationally accepted auditing standards, supporting a risk-based approach to PV audits.

The two modules are available at: www.ema.europa.eu

The ADAMAS Corporate Brochure 2016

 

Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

×
Regulatory Environment

 

The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.

adamas-quality-assurance-services

 

ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.

 

×
How to be a Clinical Auditor

 

‘So you want to be a Clinical Auditor?’, an article written by CEO Dr. Patricia Fitzgerald.

×
Benchmarking Data

 

Please download our benchmarking data sheet, to see how these data compare with your own performance. To discuss a more detailed report, or analysis of a data subset, please get in touch.

×
Is your QMS compliant?

 

Is your QMS compliant to the upcoming ICH E6 Addendum? Download our 5-point checklist

×
ICH (E6) R2 Addendum - Step 4

 

Please enter your details to complete the download.

×

×