Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition). William Gregory
include a glossary, abbreviations, terminology, references to guidelines and templates for the EU Risk Management Plan, the PSUR/PBRER sections, and distribution requirements for reporting to competent authorities.
In summary, this is a complete and well-prepared set of documents that shapes a consistent PV System at the EU level. The documents are rich in explanations and background and anyone in the field of PV, whether in the EU or elsewhere, should read and be familiar with these documents. Many of the principles and procedures are used throughout the rest of the world as they are based on the common seminal antecedent documents of PV, namely, the Council for International Organizations of Medical Sciences (CIOMS) and ICH documents.
Volume 10 Clinical Trial PV
As with the post-marketing requirements, the regulation of drug safety surveillance during clinical development has been updated over the last several years. The changes are not as dramatic as those put in place for post-marketing surveillance but are significant. EudraLex Volume 10 has been amended and new Regulations have been put in place (2019) (see w: Regulation (EU) No. 536/2014 — https://ec.europa.eu/health/human-use/clinical-trials/regulation_en). Contrary to Post-marketing Regulation for which specific PV documents (Directives, Practices, Q&A, etc.) are issued, the drug safety surveillance rules during clinical studies are part of the clinical study regulation.
Regarding clinical trial PV, the main changes represent a simplification of the rules on safety reporting as follows:
The sponsor’s responsibilities are described in terms of collecting, recording, handling, and communicating. Additional requirements are explained regarding ethics committees, interactions with investigators, issues unique to trials (e.g., unblinding), expedited reporting, annual reporting, inspections’ outcomes disclosure, and other details.
The EMA Website
The EMA website (http://www.ema.europa.eu/ema/) contains much useful information: Regulations, Directives, Practices, Q&A Documents, PRAC meetings, presentations, position statements, videos and Standard Operating Procedures (SOPs). These are useful to read as there are many of them, and they cover many areas of PV. They give a flavor of how the EMA handles PV on an operational level.
There is a section on European Public Assessment Reports (EPARs), which contain summaries of product-specific information (by brand and generic/INN name) on the CHMP opinions in granting Marketing Authorizations. There is often interesting safety information in each document, including the SmPC and labeling as well as the scientific reviews. See http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d125.
There is a very useful section on inspections for GCP, GLP, GMP, and pharmacovigilance. The PV section contains information on relevant documents, scope and mission, Inspectors Working Group, and specific procedures and guidances governing inspections. The EU Risk Management Strategies site is http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000683.jsp&mid=WC0b01ac058067a113 .
There is an up-to-date page of links to the HAs of the EU and elsewhere, as well as other regulatory agencies and scientific organizations (http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/general/general_content_000155.jsp&mid=WC0b01ac0580036d63). The monthly reports of the PRAC are available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000537.jsp&mid=WC0b01ac058058cb18.
As the EMA was originally aimed primarily at industry and regulators, there is less consumer information compared to the FDA website or other national websites within the EU. Nevertheless, more information has been added to the website aimed at patients and the general public.
The websites of member states vary in completeness and utility even if they are now required to maintain clear communication and full transparency. They are in the native language of each country, though many have some sections in English (not always the PV section). The website of the French HA, the Agence Nationale de Sécurité du Médicament (ANSM), is useful but is in French (http://ansm.sante.fr/). The Dutch Agency’s website (https://www.igj.nl/) has a section on PV in English, as does the German Agency (https://www.bfarm.de/DE/Home/home_node.html). However, many of the key documents are in the national languages and are not translated into English.
European Network of Centers for Pharmacoepidemiology and Pharmacovigilance
European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP) is a network of centers throughout Europe (not just the EU) with nearly 100 centers in 21 plus countries, including medical centers, healthcare databases, electronic registries, and other existing networks. Their goal is to further strengthen PV and pharmacoepidemiology in the EU by facilitating the conduct of high quality, multi-center, independent post-authorization studies (PAS), both safety and efficacy (PASS or PAES), with a focus on observational research. They have worked on several projects, including a checklist of operational research standards, a code of conduct, the means to promote research in PV and pharmacoepidemiology, an EU resources database with information on data sources and research centers, a study database, and the development of methodology to promote PV research.
They are collaborating with the FDA’s Sentinel Project and Health Canada’s Drug Safety and Effectiveness Network.
It is also well worth subscribing to the e-mails from the agencies as well as various blogs and news services to stay up to date on these matters.
For more information http://www.encepp.eu/.
Newsletters and RSS Feeds
The EMA has multiple free subscriptions available from its website as RSS