Download ‘Regulatory Intelligence 6’ Now

‘Regulatory Intelligence 6’ from Acorn Regulatory is the latest edition of our e-book series that looks at the latest trends and issues in the sector. You can download your edition of the e-book by completing the form below.

In edition 6 we look at:

  • post authorisation safety studies and how they are linked to Risk Minimisation Plans,
  • what you need to consider if your EU QPPV is in the UK,
  • the impact of Knowledge Aided Assessment and Structured Application, and
  • what you need to know if you are an MAH and you are outsourcing some/all of your production

Get the ‘Regulatory Intelligence 6’ e-book straight to your inbox by completing the form below.

Recent Publications from Acorn Regulatory

What Happens Next?

Our ‘no deal’ whitepaper takes a look at the likelihood of a ‘no deal’ Brexit and how that will impact on the life science sector.

Our pharmacovigilance team look at the measures that companies need to put in place now if they are to prepare for the UK leaving the EU without a deal. The role of the QPPV has been much discussed in recent years, since the outcome of the referendum became known, and companies need to be aware of the implications that Brexit will have on that role.

The medical devices team look at the role of the EU Authorised Representative and the implications for Notified Bodies.  The devices sector is in a particular ‘state of flux’ at present with the introduction of new legislation and Brexit adds to the issues that device manufacturers need to be mindful of at this time. Download it here.

Deadline 2020 – Are You Ready?

The new medical device regulations (MDR) will come into force in May 2020.  In advance of the deadline, companies across the world are working to ensure that their devices will comply with the new regulations.  For many companies there is still much work to do. Also, companies are still actively seeking further information about the regulations and how they will be applied. Download it here.

Regulatory Intelligence 5 

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

Download it here.

About the Authors:

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

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

Dr. Danica Cvetkovic
Dr. Cvetkovic heads up our Clinical & Medical team at Acorn Regulatory. She has significant experience in the clinical and medical sector. Prior to joining our company she headed the medical department of a major pharmaceutical company in her native Serbia. You can read more articles by Dr. Cvetkovic by clicking the link below.
Other articles by Dr. Danica Cvetkovic

Marie Carroll
Regulatory Affairs Advisor
Marie Carroll is a Regulatory Affairs Advisor with Acorn Regulatory and focuses on issues relating to Chemistry, Manufacturing and Controls. Prior to joining the company she spent over 15 years in senior roles with a large pharmaceutical company. You can read other articles by Marie Carroll by clicking the link below.
Other articles by Marie Carroll

Natasha Daly
Pharmacovigilance Manager
Natasha joined Acorn Regulatory in October 2018 as Pharmacovigilance Manager. Natasha has over 11 years’ experience in the pharmaceutical industry. Her experience comes from working in a large global innovator pharmaceutical company and a large global generic company and includes drug development, post-marketing and clinical trials. Natasha`s role as pharmacovigilance manager at Acorn Regulatory is intended to ensure that the procedures in place are adhered to and that Acorn Regulatory provides a quality of service to its clients acceptable to any inspecting authority. You can read more articles by Natasha Daly clicking the link below.
Other articles by Natasha Daly