Searche

Your search for "safety" matched 67 page(s).

Showing results 1 to 10.

O, safety, quo vadis? - Volume 21, Issue

It is widely acknowledged that resolutions of difficulties tend to engender new problems. Increasingly, complex systems perpetuate increasing complexity. This discursive essay suggests that the most promising of discoveries, innovations, and…

Some considerations on the safety evaluation section of clinical study reports for studies with anticancer drugs - Volume 21, Issue

The International Conference on Harmonisation (ICH) guideline E3 describes the structure and content of clinical study reports (CSRs). However, this standard structure should be interpreted according to the type of study and data, including…

Non-interventional Post-Authorisation Safety Studies (NI-PASS): A different type of report - Volume 23, Issue

Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of…

Adverse event reporting: A brief overview of MedDRA - Volume 23, Issue

Since its inception 20 years ago, the Medical Dictionary for Regulatory Activities (MedDRA) has become the lingua franca of safety reporting in a regulatory context. The standardised reporting across different regulatory regions and languages is a…

Expanding the safety horizon: How real-world evidence shapes drug safety - Volume 34, Issue

Real-world evidence (RWE), generated from real-world data (RWD), is pivotal in evaluating the safety and effectiveness of medical treatments beyond the controlled settings of clinical trials. Unlike randomised controlled trials (RCTs), which often in…

Risk management plans in the EU: Managing safety concerns - Volume 29, Issue

The preparation of pharmacovigilance documents is related to ongoing activities during the life cycle of a medicinal product and encompasses crucial processes beyond writing: strategic planning and inter disciplinary work in the context of…

Regulatory submissions of non-interventional post-authorisation safety studies - Volume 26, Issue

The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in common technical…

Writing in plain language for the Summary of Safety and Clinical Performance: Communicating medical device safety and performance data to patients - Volume 34, Issue

Effective communication with patients is paramount in the medical field, particularly in the medical device sector, where the complexity of information can create barriers to understanding. The Summary of Safety and Clinical Performance (SSCP) has…

Cosmetic regulatory writing - Volume 23, Issue

On 11 July 2013, a new regulation for cosmetics was applied in Europe, Regulation (EC) 1223/2009, replacing Directive 76/768/CEE. This new regulation clarifies the roles and responsibilities of all stakeholders and introduces new notions such as…

Reporting non-interventional post-authorisation safety studies (NI-PASS) - Volume 26, Issue

Post-authorisation safety studies (PASS), whether interventional or, more commonly, non-interventional (NI), can be used by entities such as the European Medicine Agency´s Pharmacovigilance and Risk Assess ment Committee to oblige drug companies to…

Visit the EMWA website

Search

Links

The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies

Scope

Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.

Medical Writing is listed in the following indexes: