Regulatory Group

The EMIG Regulatory Group hold regular information sharing and networking meetings for those members working in Regulatory Affairs, related disciplines or those with an interest in understanding more about current challenges impacting the industry.

The Group meets at least three time a year in London. Each meeting focuses on current hot topics and take the form of presentations and/or group discussions. External experts and Regulatory Authority personnel are often invited as appropriate. Examples of recent topics include:

  • GMP/GDP – led by MHRA inspectorate
  • source Transfer Masterclass – group discussion around current challenges
  • patient Information.

Events are a valuable networking opportunity, with time allocated at the start of each session for informal networking.

In addition, the EMIG Regulatory Group takes the lead on two key MHRA meetings for our membership:

  • cross trade meeting
  • bi-lateral meeting.

The Group was established in 2008 and is developing along with EMIG member requirements to ensure it has value for all.

We always welcome input from EMIG members to highlight topics they wish to see covered in our Regulatory Group events and also to participate in the MHRA meetings.

About the Chairs

Karen Real

With over 20 years industrial experience in the pharmaceutical industry, Karen has an extensive network of contacts in the pharmaceutical industry around Europe. This provides her with an opportunity to contribute to industry and competent authority discussions, helping to shape regulatory policy in the UK and EU.

Karen progressed from a technical position with the (then) Glaxo Group Research in the UK to hold Regulatory positions with the Merck Generics Group in both the UK and Ireland, with Dermal Laboratories in the UK and, prior to establishing Real Regulatory, with a Contract Research Organisation based in Dublin, Ireland.

Karen has an excellent track record in development strategy, driving and managing virtual teams, regulatory aspects of supply chain rationalisation, regulatory aspects of clinical trials, managing GCP compliance, gaining approvals for marketing authorisation applications and lifecycle management of approved products in Europe.

To contact Karen with regards to the Regulatory Group:

Jonathan Trethowan PhD BSc FTOPRA

Jonathan has over 20 years of industry experience holding positions at GSK and ML Laboratories before founding TRAC – The Regulatory Affairs Consultancy in 2001.  He has extensive experience of leading regulatory projects throughout the product lifecycle.

Jonathan also sits on a number of committees and steering groups for The Organisation for Professionals in Regulatory Affairs (TOPRA).  He was the TOPRA President in 2014.

To contact Jonathan with regards to the Regulatory Group:

Regulatory Group Events

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Downloadable Files:

EMA SPOR Programme Data Mapping Activities 2.3.17

IDMP Update Dr Andrew Marr 2.3.17

Identification of Medicinal Products Gabriel Boronat 2.3.17

Regulatory Group Meeting Outputs 22.3.17

EMIG Brexit Meeting March 2017 – Meetng Outputs Report

Source Transfer Masterclass, TRAC Services 8.11.17

MHRA GDP:GMP Slides March 2018