Happy New Year.

1 week ago

We start 2021 full of hope and optimism that this year will be a positive one for our valued customers and suppliers.

This time last year we were looking ahead to Brexit and the MDR, and the changes they would bring to UK/EU regulatory affairs. Businesses in the UK were planning ahead for alternate realities and VAT rules, according to deals that might be struck with our largest trading partner.

No one imagined that more disruption was around the corner, in the form of the COVID-19 pandemic.

DWL was already in the process of reducing our reliance on physical workspaces and had moved paper operations over to a digital format.

So as COVID cases rose and social distancing was enforced, we were able to move all operations to a remote setup and, like many companies, are now embracing that remote model.

After a successful 2020, we have much to look forward to in the next 12 months.

Towards the end of January, it’s Medicines for Europe’s 20th Regulatory Affairs and Pharmacovigilance (virtual) event. Last year’s event was a fantastic opportunity to get a refresher on the EU regulatory landscape.

Our Medical Director, Dr Iain Matheson, will report on “The Dawn of a New Era for UK Clinical Research?“, an event organised by the Clinical and Contract Research Association (CCRA) analysing the threats and opportunities facing the UK post-Brexit.

In February DWL will host a webinar, sponsored by TOPRA (The Organisation for Professionals in Regulatory Affairs), on Overcoming translation hurdles as a Marketing Authorisation Holder.

We will examine the varying approaches taken by customers on the path to successful marketing authorisations in Europe. We’ll offer advice and tips to save time and money when managing new submissions/variations, and promote accuracy during the Opinion and post-Opinion linguistic review stages.

Our Medical Devices working group is making sure we are up-to-date on MDR requirements heading into our customers’ May deadline, and in particular we look forward to discussing translations for combination drug/device products with potential customers this year.

We are pleased to have recruited a new team member to support our excellent team of project managers and training is well underway this month.

Also on the calendar is an interview with a tri-lingual Medical Device Consultant from the US, giving us his take on language learning and medical device regulations across the pond.

Since face-to-face conferences are on hold for now, we look forward to online networking and presenting opportunities throughout the year which will allow us to catch up with our industry colleagues from around the world, and forge new connections.

Stay in touch for more news and the results of our upcoming Customer Satisfaction Survey, coming soon.

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