Download ‘Regulatory Intelligence 5’ from Acorn Regulatory

We have published our latest e-book ‘Regulatory Intelligence 5’.  This edition features a number of new articles from our expert staff.  The articles look at a range of issues, many of the topics were suggested by clients or visitors to our website. 

In this edition we look at the following topics:

  • Pharmaceutical Development for Historic Dossiers
  • Good Pharmacovigilance Practice (GvP) & Social Media
  • The EU MDR & The Authorised Representative
  • Advice for Companies Attending Scientific Advice Meetings

and

  • What You Need To Know About MRP Grouped Variations

You can download the ‘Regulatory Intelligence 5‘ by completing your details below.

Acorn Regulatory publishes regular e-books and whitepapers on issues related to regulatory affairs, pharmacovigilance, quality compliance and much more.  Our whitepapers have been downloaded tens of thousands of times by specialists throughout the world.

No Deal Brexit Whitepaper

Some of our most recent publications include our ‘no deal’ Brexit whitepaper.  ‘What Happens Next?’, published earlier this year, considers the impact of the UK leaving the EU without a deal on October 31st.  The whitepaper, which has been downloaded thousands of times since publication, looks at the impact that might be felt by companies in the life sciences sector.

You can download your copy of ‘What Happens Next? here.

Are You Ready for MDR?

The new medical device regulations are scheduled to come into force on May 26th 2020.  Between now and then, companies in the device sector have many issues to consider.  Who will act as the Person Responsible for Regulatory Compliance? What are the new responsibilities of an EU Authorised Representative under the more stringent MDR?  These, and others, need to be considered by device manufacturers and their trading partners.  This whitepaper looks at those issues.  Get your copy here.

 

 

 

About the Authors
Brian Cleary
Chief Marketing Officer
Brian is Chief Marketing Officer at Acorn Regulatory. He works with our growing team to highlight some of the most important issues in regulatory affairs and pharmacovigilance. Brian also manages HR and recruitment issues for the company. You can read other articles by Brian by clicking the link below.
Other Articles by Brian Cleary
Christine McGrath
Senior Regulatory Affairs Advisor
Christine McGrath is an experienced Senior Regulatory Affairs Advisor at Acorn Regulatory. She works with companies around the world on issues relating to pharmaceutical regulatory affairs. At present, she is also working with our Clinical team on a groundbreaking veterinary clinical trial. You can read more articles by Christine by clicking the link below.
Other articles by Christine
Gemma Robinson, PhD
Managing Director
As Managing Director of Acorn Regulatory, Gemma Robinson is actively involved on client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance and clinical trial experts.  Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects. You can read more articles by Gemma by clicking the link below.
Other articles by Gemma Robinson PhD
Orla Keane
Medical Devices Manager
An engineer by background, she has 15 years experience in medical devices. Prior to joining Acorn Regulatory, she spent over 12 years at the HPRA in various roles within the medical devices team. She was responsible for a team within post market surveillance and vigilance across various general and active implantable medical device product families. Orla also served as co-Chair of the Compliance and Enforcement working group in Brussels for many years. She has previous industry experience at an orthopaedic implant manufacturer. Orla currently assists Acorn Regulatory clients in a variety of areas including regulatory strategy, EU authorised representative support and preparation for MDR, particularly on the topic of post market surveillance. You can read medical device and related articles written by Orla Keane by clicking the link below.
Other articles by Orla Keane