The Top 5: August 2018

31st August 2018 (Last Updated December 3rd, 2018 10:52)

CTA highlights the best articles from the month of August 2018

The Top 5: August 2018
What made this month’s Top Five?

There were numerous articles in August 2018 that covered a wide range of topical issues. Here are five of the best stories you might have missed… (Click the headline to finish reading the story)

Brexit – Where is the UK going?

The U.K. has been an uneasy member of the European Union for many years and it came as no total surprise when on June 23, 2016, the U.K. population voted to step out of the EU and Brexit was born.

Many false and confusing rumors have followed including a typical ministerial statement made by a “Brexiteer MP” (Member of Parliament) that the U.K. “will keep the European Medicines Agency (EMA) in London.” This has since been clarified as an impossibility by the EMA itself. The Agency is clearly working under the assumption that the U.K. will become a “third country” as of the March 30, 2019 and that it will have to leave London and relocate to another EU country.

MDR 2017/745, the New Code of the Medical Device Regulation

Since May 2017, a new Medical Device Regulation (MDR) came in force with a transition period of three years. Medical Device manufacturers have until the end of 2019 to comply with it. The scope of this regulation has increased as even some non-medical products as cosmetic contact lenses and esthetic surgical implants are included (Annex 16). For manufacturers of such devices, this new regulation can be critical as they are not used to such requirements.

Industry Viewpoints: Effectively Outsourcing Early Phase Clinical Trials

In recent times, trial sponsors have increasingly turned to running clinical trials abroad to benefit from an increase in patient pools coupled with cheaper operating costs. However, with that approach comes the potential pitfalls of securing comparator drugs and ensuring the data is universally accepted by the FDA and the EMA.

In this Industry Viewpoint, Elizabeth Williams talks to Jeffrey Hausfeld, who’s the Chief Medical Officer of BioFactura, Inc. Here, Hausfeld provides insight into how to effectively outsource your clinical trials and how these partnerships are evolving to stay at the forefront of the clinical trial world.

Considerations for Manufacturing Investigational Medicinal Products for Clinical Studies

Manufacturing drug products for clinical studies present many unique challenges that contrast to the manufacturing of commercial drug products. This article will explore the uniqueness of manufacturing IMPs (investigational medicinal products). Additionally, careful consideration will be paid to the planning phase and the challenges associated with manufacturing and packaging.

How to Maximize Randomization and Trial Management Systems in Clinical Studies

Running a clinical trial is getting increasingly complex and costly, regardless of the size of the company.

While carrying out a study in the pharma development environment follows a standardized path both in terms of requirements and deliverables, the specificities of this exercise can differ dramatically depending on the availability of budget and human labor.

This article aims at assessing the best solution for small to medium enterprises (SMEs) to achieve clinical operations excellence. The focus highlights how Randomization and Trial Management Systems (RTMS), and Interactive Response Technology (IRT) platforms are best suited to ensure flexibility and control of trial operations while minimizing the administrative burden.

 

In case you missed the Medical Devices spotlight last month, click here to read exclusive articles delving into the current issues and concerns involving medical device trials.