It has been more than 7 years since the first website of Safety Observer was launched and it was time for an upgrade. The new website brings a modern look and corrects the issues we had with the former platform. It includes a "News" section where we will publish free content on a regular basis. This comes in replacement of the blog published on this Blogger platform, which will no longer be maintained. Please visit the "News" section of the Safety Observer website to access our future articles. The relevant content has also been migrated from this blog to the new website ..read more

The Reference Safety Information (RSI) in Clinical Trials has been one of our favorite topics since we started this blog. I first wrote about it in January 2018 after the Clinical Trials Facilitation Group (CTFG) issued their guidance document entitled "Questions and Answers – Reference Safety Information (RSI)". In addition to presenting the main points of the guidance, I provided an overview of the background and the issues raised by MHRA Inspectors on this topic: link here The CTFG guidance was a major step forward, which brought clarifications on many aspects to set the regulatory expectat ..read more

Further to the recent good news regarding the efficacy of COVID-19 vaccine candidates, European Authorities have published new guidance documents to support Risk Management activities for these vaccines once they are authorised.     ⇒    Link to EMA News Release Photo by Daniel Schludi on Unsplash CoreRMP19 requirements and guidance This includes a new guidance document published by the EMA to help companies prepare the Risk Management Plan (RMP) for their COVID-19 vaccines, which complements the existing GVP Guidelines and the associated RMP template ..read more

LAST UPDATED 08-Sep-2020: Changes in the downloadable report are highlighted in Green. PRIOR UPDATE 06-Jul-2020 _______________________________________ We are happy to share with you the result of our Regulatory Intelligence Monitoring regarding the guidance issued to address the COVID-19 pandemic. We are highlighting the impact on Safety Reporting procedures for both Clinical Trial and Post-Marketing Pharmacovigilance activities. This information will be updated as necessary. DISCLAIMER:This is not intended to cover all countries worldwide. For more information about t ..read more

ATTENTION !! This post was updated on 20-May-2020 to reflect the changes brought by the revised version of the Guidance Document published by the FDA on 11-May-2020. Resulting revisions are tracked (in Red & Highlighted in Yellow). The U.S. FDA has published a new Guidance Document on 19-Mar-2020, which is entitled : “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic”. This is not exactly a new document and in reality, this represents a minor revision of the 2012 guidance on “Postmarketing Adverse Event Reporting f ..read more

Things are changing fast in Algeria: It has only been a few months since a Note was published to describe revised Safety Reporting requirements (see Post) and the Algerian Authorities have now published a full Pharmacovigilance Guide with new changes to expedited reporting requirements. The new Guide was produced by the "Centre National de Pharmacovigilance et de Materiovigilance" (CNPM) and includes a description of the local Pharmacovigilance System in Algeria. It covers the role of the stakeholders and includes a description of the obligations applicable to the Pharma Industry ..read more

ATTENTION !! UPDATE 09-Jan-2020: This post is no longer current as the CNPM has published a new Pharmacovigilance Guide with revised ICSR reporting requirements (see New Post). The content of this post includes the resulting revisions (in Red & Highlighted in Yellow). The Algerian Authorities have published an important revision of the Note describing the Pharmacovigilance reporting requirements in the country. Until now, the "Centre National de Pharmacovigilance et de Materiovigilance" (CNPM) required that all Serious ICSRs and Clinical Trial SUSARs be submitted, including foreign ..read more

Until now, I have used this blog to report on changes in the requirements applicable to Pharmacovigilance. This time is different and I would like to share the learning I took from a project I am involved with. The story starts in the summer of 2017 when I received a call from a contact in the Global Pharmacovigilance group at Bayer. This contact knew me as a Pharmacovigilance Auditor and asked whether I would be interested to work on a coaching module. This module was part of a training programme the company was putting together to make people better prepared for Pharmacovigilance Audits and ..read more

As reported in Safety Observer N°150 of November 2018, the ABPI (Association of the British Pharmaceutical Industry) has worked with BHBIA (British Healthcare Business Intelligence Association) to produce a revised version of their guidance on collecting Adverse Events, Product Complaints and Special Situations Reports during Market Research Programmes (MRPs). This is Version 4 of this valuable guidance document, which was first issued in October 2009. In addition to changes related to Personal Data Protection, the main change concerns the collection of contact details when information i ..read more

As reported in Safety Observer N°148 of September 2018, the EMA has published the minutes of the 100th Management Board meeting, which took place on 06 and 07-Jun-2018. The Board discussed a great variety of topics, including Brexit and lessons learnt after the first EMA Public Hearing. It also included a discussion on a report exploring the experience made with the list of products subject to additional monitoring, also known as the list of Black Triangle Products. As described in GVP Module X, all medicines on the list must be identified with an inverted Black Triangle, which is displa ..read more