Bioscript at EMWA 2019
In May, four writers from Bioscript’s Regulatory group attended the 48th European Medical Writers Association (EMWA) Conference in Vienna, Austria. Running from 7th — 11th May, the conference attracted over 440 medical writers and related professionals, hosting a varied program of workshops, seminars and networking events. This made it the largest conference that EMWA has run to date, but they still kept us all very well fed at the Intercontinental Hotel in Vienna; the networking event and buffet on the first day were a rewarding introduction to the event after many hours of travelling!
Our very own Andrew Walker led a workshop on Bacterial Infections: A Guide for Regulatory Writers for the third year running. Rye Strutt, Kina Patel and Kathryn Humfrey each attended a full program of workshops during the day, whilst some fantastic social events filled the evenings. New regulations were discussed, clinical documents were explored in depth, and the topic of Brexit reared its head on occasion! On top of the expert training provided by the workshop leaders, there was a lot to be learned from other attendees — varied backgrounds and experiences allowed contribution of invaluable questions and tips at each workshop.
Here, we’ve highlighted some of the workshops we attended.
Clinical Study Reports (CSRs): Mastering the Essential Skills
On the first day of the conference, we dived into a full day course on mastering CSRs. Knowledgeable writers Monika Milani and Sarah Hopwood took us through the CSR authoring process, including preparation (do you all have the documents you need?), how to run a kick-off meeting, managing and communicating with your team, and CSR structure. Practical workshop exercises covered different ways of presenting data, identifying objectives, defining variables and endpoints (often used interchangeably), and describing data. The workshop also highlighted relevant guidelines including the CORE reference guidance, a useful document combining ICH E3, the ICH E3 questions and answers document, and Clarity and Openness in Reporting (CORE).
Writing a Clinical Study Protocol (CSP)
The always entertaining Debbie Jordan and Wendy Kingdom delivered a comprehensive halfday course on writing a CSP. A highlight of the morning was arranging the steps involved in making a souffle (wait, what course is this again?), emphasising the importance of providing clear and concise instructions and how missing information can lead to study issues and/or delays (or ruin a recipe!). Debbie and Wendy suggest starting with a well thoughtout study flowchart depicting all visits. This, along with the schedule of assessments, is a very useful reference for study staff.
Writing Global Clinical Submission Dossiers using the Common Technical Document (CTD)
A fantastic halfday course run by James Visanji for those new to submissions work. In addition to reviewing the scope of the CTD and how it is implemented in different countries, the course provided practical information for authoring Module two, especially the Clinical Overview, the Summary of Clinical Efficacy and the Summary of Clinical Safety. The group exercise took us through different ways of presented integrated data. The workshop closed with James answering pre-submitted questions from the group — an engaging and informative way to end the session!
Introduction to Writing about Efficacy
This workshop, run by Helen Bridge, covered not only how to report efficacy data but how to know what to report — understanding endpoints, extracting information from the Statistical Analysis Plan, and how descriptive and inferential statistics are used to evaluate the data. This workshop focused primarily on CSRs, but the topics covered were wide ranging and applicable to many of the documents we support in Regulatory Writing.
Serving Two Masters: Comparing and Contrasting US and EU Regulations
Susan Bhatti and Art Gertel’s fast-paced, insightful halfday session compared and contrasted the US Food and Drug Administration (FDA) and European Medicine’s Agency (EMA) organisational and review structures, document expectations, processes, and interactions with the agencies, with an eye on potential future changes in the regulatory environment. Even aside from the inevitable uncertainties caused by Brexit, the global regulatory landscape is always changing!
From Pharma to Medical Devices
Raquel Billiones and Gillian Pritchard’s informative workshop guided us through the new regulations on medical devices, identifying what constitutes as a medical device and explaining why the regulations are so important. Practical exercises involved comparing Pharma processes with processes for Medical devices; from a Writer’s perspective, working with medical devices is not so different from Pharma!
Systematic Reviews
Systematic reviews expert Katharina Biester ran a halfday workshop on this complex topic. Using two published literature review reports as examples throughout the workshop, Katharina helped us navigate through the complexities of developing, evaluating the quality and reporting the results of Systematic Reviews and explained various tools for assessing quality and bias within Systematic Reviews. There was lots of discussion around the importance of study selection and the limitations of bias on the overall quality of the study, as well as the relevance of heterogeneity — a very informative session!
The Paediatric Investigation Plan (PIP)
Douglas Fiebig delivered an engaging halfday workshop on The PIP Application. Group exercises prompted lively debate on the challenges of conducting paediatric trials and why high-quality research into drugs for paediatrics is so very important — the effects of therapeutics on children cannot be assumed to be the same as for adults. This was a very comprehensive workshop that went into detail about the purpose and preparation of the PIP as well as the Regulations and the role of the Paediatric Committee (PDCO).
CSRs for Oncology
On the final day of the conference, Thomas M Schindler and Kirsten Herbach delivered a halfday workshop on CSRs in Oncology. This workshop focused on the specific challenges and idiosyncrasies of study designs for solid tumour oncology and was clear and thorough in describing the complexities of oncology trials. The session also included some welcome discussion on novel trial designs such as basket, umbrella and platform trials, and the difficulties they raise in regard to reporting. Despite the complexity of the topic, the workshop was easy to understand and very engaging!
Summary
After five days of in-depth learning and valuable networking opportunities, our writers at Bioscript returned full of enthusiasm, and eager to utilise their new knowledge. We are really looking forward to future EMWA conferences!
