Expert Seminar Series
The EMWA Expert Seminar Series (ESS) welcomes experienced medical writers, heads of medical writing departments, and industry leaders from other disciplines who are interested in the latest developments affecting the medical writing industry and playing a role in shaping the world of medical writing.
There is the option to join ESS session(s) online.
Wednesday 04 May
ESS 1 - Medical device: EU MDR - one year on
It has been a five years since the date of publication of EU MDR 2017/745, and one year since its date of application. Where are we now and where are we headed? This seminar brings together different stakeholders to discuss the changes, lessons learned, and current challenges as we navigate through the evolving landscape of the EU healthcare system.
-
9:00 AM
to
9:10 AM
-
9:50 AM
to
10:30 AM
-
10:30 AM
to
10:45 AM
-
10:45 AM
to
11:25 AM
-
11:55 AM
to
12:30 PM
ESS 2 - MedComms: The real-world impact of open science
The premise of open science is that research will progress faster if data and knowledge are openly shared with the caveat of proper safety measures and ethical frameworks. This has been most evident during the current COVID-19 global pandemic.
Therefore, with open science continuing to rise in prominence and adoption by science funders and researchers, can we demonstrate the real-world impact? This Expert Seminar will share real-world perspectives and applications of open science to accelerate clinical research and benefit patients.
-
1:30 PM
to
1:45 PM
-
2:15 PM
to
2:45 PM
-
2:45 PM
to
3:00 PM
-
3:00 PM
to
3:30 PM
-
4:30 PM
to
5:00 PM
Friday 06 May
ESS 3: A journey through marketing authorization applications from a Regulator's and a Medical Writer's perspective
This session focuses on different aspects of market authorisation processes in the EU, including the characteristics of a good marketing authorisation (MAA) application from a clinical reviewer’s perspective. The session will present advice on how to prepare a good MAA, processes and guidelines for advanced therapy medicinal products (ATMP), and accelerated authorisation procedures in the EU. The pandemic posed a unique challenge to regulators and marketing authorisation holders (MAHs) regarding the authorisation of the COVID-19 vaccines. The need for rapid evaluation in pre- and post-approval settings was addressed through various processes with specific and challenging requirements and timelines. This session will guide the audience through the regulatory journey of COVID-19 vaccines from different perspectives, including that of medical writers, and will explore how the experience gained so far could improve future pandemic and non-pandemic processes.
-
9:00 AM
to
9:05 AM
-
10:25 AM
to
10:40 AM
-
11:05 AM
to
11:30 AM
-
12:20 PM
to
12:30 PM
ESS 4: Veterinary writing in 2022 - new regulatory challenges and interfaces with human safety
The first expert seminar on the veterinary regulatory cosmos in EMWA’s history will demonstrate why the veterinary field really matters to medical writing. Our panel includes speakers from two pharmaceutical companies and a veterinary university as well as a veterinary regulatory consultancy. The session will start with an overview of the latest EU veterinary medicinal products regulations, followed by talks on why antimicrobial resistance matters in animal and human medicine and how to ensure environmental safety. Finally, a veterinary pathologist will discuss communication challenges in reporting animal studies from drug development programme, in other words – how animals keep humans safe. As the recent pandemic shows, if you are concerned with human health, it is time to address the species barrier and implement One Health. This session will give medical writers the expertise to tackle a future in which human and animal health are increasingly entwined.
-
1:30 PM
to
1:40 PM
-
1:40 PM
to
2:25 PM
-
3:10 PM
to
3:25 PM
-
3:25 PM
to
4:10 PM
-
4:55 PM
to
5:00 PM