In Case You Missed It – #ICYMI – More Articles from the Archive

Our expert team has written over 300 insightful articles on all aspects of regulatory affairs. Here, we are highlighting some of the best writing from our recent archive in #ICYMI.  In this third edition of #ICYMI (In Case You Missed It) we are featuring articles on issues as diverse as simplified adverse event reporting,  the code of practice for IPHA and the ABPI, Ireland’s location as a clinical trial location and the eSubmission roadmap.

1. The eSubmission Roadmap – What Is Happening Between Now and 2020?

The January 1st 2018 eCTD deadline is just one critical date that forms part of the overall eSubmission roadmap that looks at developments of eSubmissions between now and 2020.

What Is The eSubmission Roadmap?

The final adopted version of the roadmap was published in February of 2017 and states that the eSubmission roadmap  “is a high level strategic plan for business and technology change, typically operating across multiple disciplines over several years. It is a tool to align the plans of target groups and help National Competent Authorities (NCAs), EMA and pharmaceutical industry to prepare themselves to forthcoming changes. It clarifies objectives and activities to reach them. It sets a common timeline for development. It helps supporting strategic decisions and resource provisions. It is thus an important communication tool which helps to find a common understanding and commitment. It is therefore addressed to decision makers at executive management level”. Read more here.

2. Simplified Adverse Event Reporting in Europe – Are You Prepared for the Switch Over?

Since the introduction of the pharmacovigilance legislation in 2010, a commitment to a simplified approach to adverse event reporting was introduced by the EMA (Articles 107(3) and 107a(4) of Directive 2001/83/EC). This approach would only apply however following an independent audit of the EudraVigilance database. Ad interim, the adverse reaction reporting is based on the provisions set out in Article 2(4), Article 2(5) and Article 2(6) of Directive 2010/84/EU and in line with national legislation and guidance where applicable. This is referred to as the so-called ‘Interim period’ which continues to be in place. Read more here.

3. Clinical Trials in Ireland: Is Ireland The Place To Be?

Great progress has been made in recent years in Ireland to advance the capability in design, conduct, analysis and reporting of clinical trials. Patients, researchers, academics, clinicians and industry along with the Health Research Board have worked tirelessly to develop this framework.  Yet, with all of these developments, Ireland still only participates in less than 2% of studies in Europe.  Read more here.

4. Pharmaceutical Code of Practice – Are You Aware of Your Responsibilities?

In this article we look at the issues surrounding the code of practice that governs pharmaceutical companies in the UK or Ireland.  The IPHA and ABPI codes cover the promotion of medicines for prescribing to both health professionals and other relevant decision makers.The Irish pharmaceutical industry is governed by the IPHA (Irish Pharmaceutical Healthcare Association) code.  The UK is governed by the ABPI (Association of the British Pharmaceutical Industry) code. These have been in force and existence for many years, and year on year, they both publish updates and addendum’s to the existing code and further clarify and expand on what is the expected behaviour and standard for all companies (if a member or not) to follow.  Read more here. We will feature many more articles from our archive as the #ICYMI  In Case You Missed It series progresses.  Feel free to share any articles of interest by using any of the links below.