Welcome to REG+

REG+ gives you access to a growing number of authoritative papers, articles and reports on important Regulatory Affairs, Pharmacovigilance and Quality Assurance topics.

Total files available:
20

  • Implementation of the safety features under the Falsified Medicines Directive 2011/62/EU

    This whitepaper, written by Susannah, outlines the responsibilities and actions marketing authorisation holders, manufacturing and importation authorisation holders, wholesale distributors, software providers and persons authorised or entitled to supply medicines to the public should take in order to comply with the new safety feature requirements under the Falsified Medicines Directive.

    Last updated: November 6th, 2018 (Version: 1). File: pdf, filesize: 405 KB.

    Please log in or register to download.
  • Literature searching in Pharmacovigilance: requirements and guidance

    Literature searching in pharmacovigilance plays an important role in understanding the risk-benefit profile of medicinal products. This whitepaper discusses the importance of literature searching, use of literature databases and guidance to streamline the process. For further assistance please get in touch with us.

    Last updated: September 11th, 2018 (Version: 1). File: pdf, filesize: 512 KB.

    Please log in or register to download.
  • Brexit Q&A

    This whitepaper, written by the Regulis Team, provides information on medicinal product and medical device regulatory and pharmacovigilance requirements following Brexit.

    Last updated: August 21st, 2018 (Version: 1). File: pdf, filesize: 532 KB.

    Please log in or register to download.
  • QMS aspects of the Medical Device Regulations

    Our latest whitepaper, written by Reihaneh summarises the major Quality Management System aspects of the Medical Device Regulations as the driver of all changes for the transition.

    Last updated: July 3rd, 2018 (Version: 1). File: pdf, filesize: 269 KB.

    Please log in or register to download.
  • Mutual recognition of inspections of medicinal product manufacturers between the EU and the USA

    This whitepaper, written by Audrey summarises the scope and impact of this agreement on the pharmaceutical manufacturers and the authorities in both regions.

    Last updated: July 30th, 2018 (Version: 2). File: pdf, filesize: 518 KB.

    Please log in or register to download.
  • New responsibilities for importers, distributors and authorised representatives for medical devices

    This whitepaper by Susannah, outlines the responsibilities of medical device economic operators, in the Medical Device Regulations. If you are an EU Authorised Representative or an importer or a distributor of medical devices in the EU, this whitepaper will help you to familiarise yourself with your regulatory obligations.

    Last updated: February 8th, 2018 (Version: 1). File: pdf, filesize: 405 KB.

    Please log in or register to download.
  • Requirements of a person responsible for regulatory compliance for medical devices

    This Whitepaper, written by Susannah discusses the practical aspects for device manufacturers.  If you require support with this please get in touch with us.

    Last updated: January 15th, 2018 (Version: 1). File: pdf, filesize: 267 KB.

    Please log in or register to download.
  • Medical Device Regulation Requirements for Post-Market Surveillance, Vigilance and Post-Market Clinical Follow-up

    This Whitepaper, written by Reihaneh will give you the latest information available on the Medical Device Regulation requirements.  If you require support with this please get in touch with us.

    Last updated: November 16th, 2017 (Version: 1). File: pdf, filesize: 423 KB.

    Please log in or register to download.
  • Top tips for a successful EU Orphan Drug Designation application

    Our Regulatory team have written this guidance document to successfully guide you through an Orphan Drug application.  The team has significant in-depth knowledge and experience with ODAs so if you require support with an EU ODA including a company to act as Sponsor, please get in touch with us.

    Last updated: October 24th, 2017 (Version: 1). File: pdf, filesize: 389 KB.

    Please log in or register to download.
  • India’s Medical Devices Rules, 2017: A quantum leap capable of a revolution

    On 1st January 2018, India is all set to embrace Medical Devices Rules, 2017; the first ever device-specific regulations for its US $ 5 billion medical device market which is largely unregulated at present.  Our medical device team has written this whitepaper to elaborate what and how it will change under India’s new medical device regulations.

    Last updated: December 14th, 2017 (Version: 2). File: pdf, filesize: 563 KB.

    Please log in or register to download.
  • The new EU Medical Device Regulations - Impact on Notified Bodies and Manufacturers

    Audrey Toulemonde from our devices team reports on the impact of the new regulations on Notified Bodies and manufacturers.

    Last updated: August 8th, 2017 (Version: 1). File: pdf, filesize: 288 KB.

    Please log in or register to download.
  • Patient friendly leaflets - writing and user testing

    With Regulis’ many years of experience of writing and user testing hundreds of patient information leaflets, this paper describes the considerations and offers hints and tips for producing a patient-friendly leaflet that is in compliance with Council Directive 2001/83/EC (as amended by 2004/27/EC).

    Last updated: July 11th, 2017 (Version: 1). File: pdf, filesize: 424 KB.

    Please log in or register to download.
  • Global Early Access Schemes Part 2 of 2

    What are Early Access Schemes?  The final part of a two part white paper that Vanessa Damment from our Regulatory Affairs team has put together on Early Access Schemes, focusing on Japan, China, Australia and Canada.

    Last updated: May 4th, 2017 (Version: 1). File: pdf, filesize: 414 KB.

    Please log in or register to download.
  • Global Early Access Schemes Part 1 of 2

    What are Early Access Schemes?  Vanessa Damment from our Regulatory Affairs team has put together the first of a two part white paper on Early Access Schemes, the first one focuses on the EU and US.

    Last updated: April 10th, 2017 (Version: 1). File: pdf, filesize: 631 KB.

    Please log in or register to download.
  • Regulatory Affairs and Pharmacovigilance benefits of SME status

    In this paper the Regulatory Affairs team review the benefits of SME status and how to obtain it.

    Last updated: March 9th, 2017 (Version: 1). File: pdf, filesize: 518 KB.

    Please log in or register to download.
  • Whitepaper cover of EudraVigilance Review

    A review of the EudraVigilance Stakeholder Change Management Plan

    Upcoming Eudravigilance changes – What do you need to do to be ready?

    Last updated: February 7th, 2017 (Version: 1.0). File: pdf, filesize: 516 KB.

    Please log in or register to download.
  • Whitepaper cover of Porposed EU Medical Device Regulation

    The Proposed EU Medical Device Regulation and End of Own Brand Labelling

    The Medical Device team at Regulis have published a white paper on the proposed EU Medical Device Regulation and end to Own Brand Labelling. The MHRA have now confirmed to all UK Notified Bodies that the present process of reviewing only the summary technical documentation (STED) in relation to OBL devices is no longer acceptable under EU Commission requirements. This papers describes how such manufacturers can continue to remain compliant under the new requirements.

    Last updated: December 16th, 2016 (Version: 1.0). File: pdf, filesize: 359 KB.

    Please log in or register to download.
  • Orphan Products in the EU

    This detailed article reviewed information and metrics on orphan drug registration in the EU and makes recommendations for a successful orphan drug regulatory strategy.

    Last updated: May 4th, 2017 (Version: 1). File: pdf, filesize: 637 KB.

    Please log in or register to download.
  • Cover of the whitepaper Medical Literature Monitoring of the EMA

    The Medical Literature Monitoring of EMA

    Vatsala Patel from the Pharmacovigilance team considers the responsibilities of marketing authorisation holders and the EMA around medical literature monitoring (MLM) and reviews the EMA’s MLM service over a year on from its introduction.

    Last updated: December 16th, 2016 (Version: 1.2). File: pdf, filesize: 276 KB.

    Please log in or register to download.
  • Placing a Class I Medical Device on the Market in the European Union and the Impact of the New Regulation

    The Medical Devices team at Regulis discuss placing a Class I Medical Device on the market in the EU and the impact of the new device regulation.  Updated in October 2018.

    Last updated: October 11th, 2018 (Version: 2). File: pdf, filesize: 583 KB.

    Please log in or register to download.