RegIntel provides the following services:

Support for non-EU established companies undertaking clinical research in the EU
Regulatory Advice on EU Regulatory and Market Access
Regulatory Intelligence in EU and national European regulations
EU Legal Representative Service (per Clinical Trial Directive)
UK Legal Representative (in accordance with the Medicines Act)
Data Protection Officer service by contract
Data Protection Representative (DPR) in accordance with article 27 of the General Data Protection Regulation (GDPR)
Development of Data Protection Impact Assessments and Records of Processing Activities
Support for “getting into compliance” with the GDPR in terms of GAP analysis, policies, SOPs, Technical and Organisational Measures, data flow analysis, transfers (standard contractual clauses)
Training in GDPR with a focus on clinical research
Responsible Person for Eudravigilance Service (RPEV)
Submission of Product Data (XEVMPD) and Safety Data (ICSRs)
Marketing Authorisation Holder Service – Holding and Transfer of Products
Licensing Services (RegIntel has a wide network of clients)
EU Orphan Drug Sponsorship and Submissions
SME Registration with EMA office (Regulation (EC) No 2049/2005)
Support for Scientific Advice and Protocol Assistance procedures
EU Corporate Establishment, Governance, and Annual Returns
Data Protection Advice and Representation; ICF/protocol development
Marketing Authorisation Applications, Variations and Renewals

Regintel works with partner companies to provide:

Qualified Person Service (IMP import, EU certification, storage, transfer, labelling)
Qualified Person for Pharmacovigilance
Support for Study Set-up, Protocol, IB, CRA, PSUR, Clinical Report development
Electronic Submissions
Medical writing

About:

Breffni Martin was educated at St Micheal’s College Dublin and Cistercian College Roscrea. At University College Dublin he received his BSc specialising in biochemistry in 1983. Thereafter he worked for a number of major pharmaceutical companies in the area of late stage drug development, in both a scientific, regulatory and information technology context, as well as in environmental management. These include GlaxoSmithKline, Bristol-Myers Squibb, Laboratoire Guerbet and Fermenta (a Pharmacia spin-off).

In 1997 he joined IMS Health (IDRAC, a regulatory intelligence company) where he developed regulatory content covering North America, Japan, Australia and elsewhere, including a dedicated FDA Advisory Committee intelligence business. He subsequently set up and operated Regintel and CanReg (Europe), regulatory intelligence and services companies.

Breffni Martin is a long-standing member of the Drug Information Association (the pharmaceutical industry’s largest professional association), has served on its Advisory Council for Europe from 2004 – 2009 as well as other committees, and is a regular programme chair, speaker and contributor at DIA and other conferences.

Speaker (Challenges in Regulatory Intelligence), Annual Meeting, Washington DC, 2003.
Session chair and speaker: Three Worlds – One Voice: eClinical, CDM, Validation, Amsterdam 2004.
Programme committee, track chair, speaker (Validation methodology): Four Worlds - One Vision: Delivering Quality Data Effectively, Prague, 2005.
Session Chair: Combination Products: A Primer, DIA Annual Meeting Philadelphia 2006.
Speaker (Challenges of Data Capture from Obese Patients), Euromeeting Vienna, March 2007.
Session Chair (Risk-based Software Validation): Annual Meeting, Atlanta, 2007.
Programme committee, track chair, session chair, speaker: 2nd Clinical Forum, Slovenia, October, 2007.
Speaker (eClinical solutions for obesity epidemic) Applied Clinical Trials European Summit, October 2007, Berlin
Session Chair (Delivering Quality Validation): Annual Meeting, Boston, 2008.
Programme committee, track chair, session chair, speaker: October, 2008.3nd Clinical Forum, Nice,
Session Chair (Auditing), Annual Meeting, San Diego, 2009.
Programme committee, track chair, session chair, speaker: 4nd Clinical Forum, Monaco, October, 2009.
Speaker (Impact of Climate Change on Pharma), Annual Meeting, Washington DC, 2010.
Programme advisor, session chair, speaker (Risk Assessment Methodology): 4th Clinical Forum, Lisbon, 2010.
Programme committee, Session Chair, Speaker (Risk-based Validation – the keys to success) 5th Annual Clinical Forum, Basel 2011
Speaker (Regulatory Intelligence) Movida Annual Registration Summit Warsaw February 2011
Programme Committee, Session Chair (Cloud Computing In GXP Regulated Environment) 6th Annual Clinical Forum, The Hague, 2012
Programme Committee, Chairman and speaker (The Smart Approach to ePRO – mobile devices), 7th Annual Clinical Forum, Dublin, 2013
Programme Committee, Session Chair, Facilitator, "Maintain Data Integrity to Reduce Risk for the Patient" - DIA/ISPE Workshop Basel, Switzerland 2014
Speaker (The Risk of Risk Assessment), DIA Annual Meeting, Washington DC, 2015
He is a bilingual French-English speaker.

Recent Publications

Article: Data Protection and The Cloud in Multiple Countries (or Dude, Where’s My Data?) covering cloud and data protection issues in the EU, published in DIA Global Forum, August 2014.

Book chapter: “ePRO Applications and Personal Mobile Phone Use” a chapter in “Electronic Solutions for Patient-Reported Data” published by Gower October 2010 (editors Byrom/Tiplady).

He has also published numerous papers and articles on ecology and birds in particular. In his spare time he is a published wildlife photographer and volunteers for several wildlife organisations including Birdwatch Ireland, Irelands largest Conservation NGO, of which he is a board member, and the Louth Nature Trust, of which he is a founder and director. He also works with the local County Council on environmental issues where he serves on the Local Community Development Committee and the Strategic Policy Committee on Environment, as well as the Loughs Agency and the Heritage Committee.

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