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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:
29

  • How will medicines be regulated if the UK leaves the EU?

    If you have a medicinal product on the market in the UK, an application for medicinal product which involves the UK or are developing a medicinal product intended for the UK, read our latest whitepaper on your obligations and some guidance in the event of a 'no-deal' Brexit.

    Last updated: September 5th, 2019 (Version: 1). File: pdf, filesize: 231 KB.

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  • EU Drug Registration Procedures

    This whitepaper provides a high level narrative into the possible procedures into obtaining a Marketing Authorisation (MA) for a medicinal product in the European Union. It gives a brief overview of the timelines involved in each procedure as well as information on the EU’s allowance for data exclusivity.

    Last updated: August 9th, 2019 (Version: 1). File: pdf, filesize: 162 KB.

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  • Monitoring Compliance with Safety Exchange Agreements

    Monitoring of compliance via a safety data exchange agreement (SDEA) or pharmacovigilance agreement (PVA) is vital in order to ensure that regulatory requirements are being met. In this whitepaper, we describe the importance of these agreements and the organisations that are required to maintain them.

    Last updated: July 11th, 2019 (Version: 1). File: pdf, filesize: 285 KB.

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  • Implementation of Eudravigilance Data Analysis System (EVDAS) in signal detection

    This whitepaper discusses the requirements of analysing Eudravigilance data for signal management, including the new EVDAS system. Find out MAH responsibilities, how to implement the information and what to expect from the EM.

    Last updated: May 13th, 2019 (Version: 1). File: pdf, filesize: 399 KB.

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  • How will medical devices be regulated, if the UK leaves the EU without a deal?

    NOW is the time to take action!  If you are a manufacturer, authorised representative, importer or distributor of medical devices based in the UK, or market your medical devices in the UK, read our latest whitepaper on your obligations after Brexit in the event of a 'no-deal'.

    Last updated: April 8th, 2019 (Version: 1). File: pdf, filesize: 317 KB.

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  • Time to change the Rules!

    The release of the MDR and the IVDR, brings some significant changes to the Classification Rules for Medical Devices and In-Vitro Diagnostics. This will affect a lot of devices and their manufacturers. Find out how your device could be affected in this whitepaper.

    Last updated: March 11th, 2019 (Version: 1). File: pdf, filesize: 340 KB.

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  • Image for whitepaper - Text reads: Preparing for a Good Pharmacovigilance Practice MHRA Inspection

    Preparing for a Good Pharmacovigilance Practice MHRA Inspection

    If you are currently preparing for a Good Pharmacovigilance Practice (GPvP) Medicines and Healthcare products Regulatory Agency (MHRA) inspection, or would like to be prepared in case of an unannounced inspection, then this whitepaper provides valuable guidance on what to expect and how to prepare for the inspection. This whitepaper also highlights common critical and major findings from MHRA GPvP inspections.

    Last updated: February 12th, 2019 (Version: 1). File: pdf, filesize: 551 KB.

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  • Image for whitepaper - Text reads: When your Notified Body is losing its designation under the Medical Device Regulation - how to effectively prepare for the change.

    Preparing to change your European Notified Body

    We are more than half way through the Medical Device Regulation (MDR) transition period (Date of Application 26th May 2020), but unfortunately not all Notified Bodies will be in a position to be designated under the MDR. This whitepaper has been written by Vanessa Plummer (Senior Regulatory Executive at Regulis), to provide affected device manufacturers with some guidance on the options available and how best to plan for the upcoming date of application.

    Last updated: March 25th, 2019 (Version: 1). File: pdf, filesize: 549 KB.

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  • Image for whitepaper - Text reads: Tips for writing an outstanding Clinical Overview

    Tips for writing an outstanding Clinical Overview

    If you are writing or due to write a Clinical Overview, our whitepaper gives you some valuable guidance to help get you started or give you some tips for the future.  Written by one of our experts, we are sure you will find it interesting and informative.

    Last updated: December 10th, 2018 (Version: 1). File: pdf, filesize: 582 KB.

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  • Image for whitepaper - Text reads: Implementation of the safety features under the Falsified Medicines Directive 2011/62/EU

    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.

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  • Image for whitepaper - Text reads: Literature searching in Pharmacovigilance: requirements and guidance

    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.

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  • Image for whitepaper - Text reads: Brexit Q&A

    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.

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  • Image for whitepaper - Text reads: QMS aspects of the Medical Device Regulations

    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.

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  • 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: August 8th, 2019 (Version: 3). File: pdf, filesize: 609 KB.

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  • Image for whitepaper - Text reads: New responsibilities for importers, distributors and authorised representatives for medical devices.

    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.

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  • Image for whitepaper - Text reads: Requirements of a person responsible for regulatory compliance for medical devices.

    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.

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  • Image for whitepaper - Text reads: Medical Device Regulation Requirements for Post-Market Surveillance, Vigilance and Post Market Clinical Follow-up

    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.

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  • Image for whitepaper - Text reads: Top tips for a successful EU Orphan Drug Designation application

    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.

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  • Image for whitepaper - Text reads: India's Medical Devices Rules, 2017: A quantum leap capable of a revolution

    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.

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  • Image for whitepaper - Text reads: The new EU Medical Device Regulations - Impact on Notified Bodies and Manufacturers

    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.

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  • Image for whitepaper - Text reads: Patient friendly leaflets - writing and user testing

    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.

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  • Image for whitepaper - Text reads: Global Early Access Schemes Part 2 of 2

    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.

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  • Image for whitepaper - Text reads: Global Early Access Schemes Part 1 of 2

    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.

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  • 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.

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  • 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.

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  • 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.

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  • Image for whitepaper - Text reads: Orphan Products in the EU

    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.

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  • 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.

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  • Image for whitepaper - Text reads: Placing a Class I medical device on the market in the European Union and the impact of the new regulation

    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.

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