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Wed, 08 Aug 2018 10:00:00 -0000 Robin Kerbel As we are now a couple of months in after the enforcement of GDPR, we ask Robin Kerbel, CEO and co-founder from Six Degrees Medical* what the impact on the pharma sector is and what may be the wider implications of the regulation changes… https://www.epmmagazine.com/opinion/data-protection-its-personal/ https://www.epmmagazine.com/opinion/data-protection-its-personal/ Wed, 08 Aug 2018 10:00:00 -0000 data protection Mark Davison In this online opinion piece, Mark Davison, head of operations in the EU for rfxcel, outlines everything marketing authorisation holders (MAHs) need to know and what is needed for a seamless serialisation process https://www.epmmagazine.com/opinion/drastic-measures-what-mahs-should-know-about-eu-fmd/ https://www.epmmagazine.com/opinion/drastic-measures-what-mahs-should-know-about-eu-fmd/ Wed, 11 Jul 2018 11:45:33 -0000 EU FMD Paul Brooks In this online exclusive, Paul Brooks, executive director, Regulatory Affairs Professionals Society (RAPS), looks at the impact Brexit may have on the healthcare product regulatory space and how clarity is urgently needed. https://www.epmmagazine.com/opinion/brexit-and-healthcare-product-regulation-navigating-the-grey/ https://www.epmmagazine.com/opinion/brexit-and-healthcare-product-regulation-navigating-the-grey/ Fri, 06 Jul 2018 11:41:19 -0000 Brexit John Johnson In this article, John Johnson, vice president, Pharma Biotech, NSF International, looks at the revision to Annex 1 and the important questions steriles manufacturers and pharma suppliers should be asking themselves. https://www.epmmagazine.com/opinion/asking-the-right-questions/ https://www.epmmagazine.com/opinion/asking-the-right-questions/ Tue, 19 Jun 2018 13:18:30 -0000 questions Gill Wright As the deadline approaches for companies to be compliant with the new legislation to apply serialisation codes to every applicable pack of product, Gill Wright, design & development director, Cirrus, asks if you are ready for FMD… https://www.epmmagazine.com/opinion/the-clock-is-ticking-for-fmd-compliance/ https://www.epmmagazine.com/opinion/the-clock-is-ticking-for-fmd-compliance/ Tue, 19 Jun 2018 11:15:43 -0000 clock Pooja Phogat Pooja Phogat, regulation and compliance expert at Kinapse, advises on the best approaches to balancing the risk of patient re-identification with the need for greater data utility. https://www.epmmagazine.com/opinion/achieving-the-desired-end-goal/ https://www.epmmagazine.com/opinion/achieving-the-desired-end-goal/ Fri, 25 May 2018 10:00:00 -0000 end goal Mark Stevens As the General Data Protection Regulation (GDPR) take effect this month, Mark Stevens, managing director, Formpipe Life Science, looks at the key differences companies should be aware of and how they can attain compliance. https://www.epmmagazine.com/opinion/getting-a-handle-on-gdpr/ https://www.epmmagazine.com/opinion/getting-a-handle-on-gdpr/ Fri, 25 May 2018 09:00:00 -0000 handle The European Medicines Agency (EMA) has accepted Sanofi’s regulatory submission for sotagliflozin, a potential treatment for type 1 diabetes, for review. https://www.epmmagazine.com/news/mea-accepts-marketing-authorisation-submission-for-sotagliflozin/ https://www.epmmagazine.com/news/mea-accepts-marketing-authorisation-submission-for-sotagliflozin/ Thu, 29 Mar 2018 11:27:36 -0000 Type I diabetes Today (Friday 9 Feburary 2018) marks the precise point that we are a year away until the European Union Falsified Medicines Directive (EU FMD) comes into force. Here, we feature some expert opinions https://www.epmmagazine.com/opinion/the-final-countdown-is-on-for-eu-fmd-compliance-what-are-the/ https://www.epmmagazine.com/opinion/the-final-countdown-is-on-for-eu-fmd-compliance-what-are-the/ Fri, 09 Feb 2018 12:24:23 -0000 Timer NSF International In this article, NSF International goes into detail about what the potential ramifications of Brexit may be on the regulatory landscape in pharma. https://www.epmmagazine.com/opinion/potential-impacts-of-brexit-on-pharma/ https://www.epmmagazine.com/opinion/potential-impacts-of-brexit-on-pharma/ Wed, 07 Feb 2018 12:00:00 -0000 Brexit rethink Dan Anslow Here, Dan Anslow, UK sales manager, Crest Solutions, shares some key tips and insights, learned through partnering with pharmaceutical manufacturers that have already successfully implemented solutions for serialisation, aggregation and Track & Trace https://www.epmmagazine.com/opinion/did-you-know-how-to-implement-serialisation/ https://www.epmmagazine.com/opinion/did-you-know-how-to-implement-serialisation/ Wed, 07 Feb 2018 11:00:00 -0000 Did you know? Vikash Patel Here, Vikash Patel, senior regulatory specialist for ELC Group, gives us an update on the regulatory developments impacting the pharma industry as a result of Brexit. https://www.epmmagazine.com/opinion/brexit-update-regulatory-developments/ https://www.epmmagazine.com/opinion/brexit-update-regulatory-developments/ Wed, 07 Feb 2018 10:00:00 -0000 Brexit update Vikash Patel One of the potential pitfalls when preparing a product launch is planning for GMP inspections. An upside of recent events, is worksharing, leading towards a more globalised market. In this article Vikash Patel, ELC Group tells us more... https://www.epmmagazine.com/opinion/mutually-beneficial/ https://www.epmmagazine.com/opinion/mutually-beneficial/ Thu, 21 Dec 2017 09:00:00 -0000 Mutual benefit The findings from the final section (part iii) of the CPhI Annual Report have been announced by event organisers UBM. https://www.epmmagazine.com/analysis/findings-from-part-iii-of-the-cphi-annual-report-announced-b/ https://www.epmmagazine.com/analysis/findings-from-part-iii-of-the-cphi-annual-report-announced-b/ Tue, 31 Oct 2017 10:42:21 -0000 Microphones Tom Nichols With the forthcoming regulatory changes set to come into force over the next couple of years in pharma, management practices will surely be tested. In this article, Tom Nichols, Quanticate, details some of the challenges the industry will face. https://www.epmmagazine.com/opinion/the-regulatory-outlook-detailing-some-of-the-challenges-the-/ https://www.epmmagazine.com/opinion/the-regulatory-outlook-detailing-some-of-the-challenges-the-/ Wed, 25 Oct 2017 11:00:00 -0000 Outlook Sonia Monahan Master data management promises an efficient, definitive way to address the demands of the forthcoming ISO IDMP standards for product information recording. What is involved in practice though, and how can companies ensure the investment pays off? https://www.epmmagazine.com/opinion/mastering-idmp-%E2%80%94-what%E2%80%99s-involved-in-master-data-management-a/ https://www.epmmagazine.com/opinion/mastering-idmp-%E2%80%94-what%E2%80%99s-involved-in-master-data-management-a/ Wed, 25 Oct 2017 10:00:00 -0000 Mastering IDMP Madalina Huruba Pharmacovigilance is a dynamic clinical and scientific discipline that has had an important impact on the public health environment. Madalina Huruba, ELC Group, goes into the history and the necessity of an effective pharmacovigilance system https://www.epmmagazine.com/opinion/the-impact-of-pharmacovigilance-on-the-public-health-environ/ https://www.epmmagazine.com/opinion/the-impact-of-pharmacovigilance-on-the-public-health-environ/ Wed, 25 Oct 2017 09:00:00 -0000 Impact In this instalment, we find out about the life, loves and career drivers of the new director of Regulatory Affairs and QP Services at Wasdell, Colin Newbould. https://www.epmmagazine.com/opinion/meet-the-maker-epm-talks-to-colin-newbould/ https://www.epmmagazine.com/opinion/meet-the-maker-epm-talks-to-colin-newbould/ Tue, 10 Oct 2017 12:36:38 -0000 Meet the maker Bruno Speder Bruno Speder, SGS Life Sciences, gives an overview of new EU regulation 536/2014, introduced to provide a single European submission and approval procedure for clinical trials, and discusses the effects it may have on early phase clinical trials https://www.epmmagazine.com/opinion/clear-and-clinical-an-overview-of-the-new-eu-regulation-for-/ https://www.epmmagazine.com/opinion/clear-and-clinical-an-overview-of-the-new-eu-regulation-for-/ Fri, 04 Aug 2017 11:19:40 -0000 Clear and clinical Dr Rajendra Wable Dr Rajendra Wable, subject matter expert-medical writing and regulatory affairs at ‎Sciformix Corporation, discusses how marketing authorisation applications across Europe, Australia and other countries can be supported with non-clinical overviews https://www.epmmagazine.com/opinion/outside-support-%E2%80%94-supporting-marketing-authorisation-applica/ https://www.epmmagazine.com/opinion/outside-support-%E2%80%94-supporting-marketing-authorisation-applica/ Tue, 01 Aug 2017 14:44:55 -0000 Outside Support Dr Prashanth BSB Dr Prashanth BSB, head of safety and medical writing for ELC Group, talks to EPM about the ramifications Brexit may have on the pharmacovigilance landscape. https://www.epmmagazine.com/opinion/a-changing-landscape-%E2%80%94-what-will-be-the-brexit-ramifications/ https://www.epmmagazine.com/opinion/a-changing-landscape-%E2%80%94-what-will-be-the-brexit-ramifications/ Mon, 31 Jul 2017 13:00:00 -0000 A changing landscape Stephie Castling As pharma anticipates the forthcoming Brexit negotiations and future uncertainty, Stephie Castling, senior marketing executive from Denny Bros, examines the regulatory concerns coming to the fore in the industry. https://www.epmmagazine.com/opinion/with-bated-breath-examining-the-regulatory-concerns-in-the-u/ https://www.epmmagazine.com/opinion/with-bated-breath-examining-the-regulatory-concerns-in-the-u/ Mon, 31 Jul 2017 09:00:00 -0000 With bated breath Lonza has revealed it has gained all regulatory approvals for its proposed acquisition of Capsugel, which the company anticipates will close over the next few days subject to the satisfaction of customary closing conditions. https://www.epmmagazine.com/news/lonza-has-received-regulatory-approval-for-capsugel-acquisit/ https://www.epmmagazine.com/news/lonza-has-received-regulatory-approval-for-capsugel-acquisit/ Tue, 27 Jun 2017 10:48:02 -0000 Regulatory approval Mac Kella Narasimharaju SN Narasimharaju SN, senior manager — regulatory affairs and Mac Kella, senior regulatory affairs executive at ELC Group assess whether biosimilars are really interchangeable in the EU. https://www.epmmagazine.com/opinion/along-bio-similar-lines-%E2%80%94-are-biosimilars-really-interchange/ https://www.epmmagazine.com/opinion/along-bio-similar-lines-%E2%80%94-are-biosimilars-really-interchange/ Thu, 15 Jun 2017 08:20:05 -0000 Along (bio)similar lines Mark Usher In this article, Mark Usher of Solidsoft Reply, explains the challenges of deploying multiple connected national systems for the large-scale European pharmaceutical industry. https://www.epmmagazine.com/opinion/challenging-scale-how-to-deploy-multiple-connected-national-/ https://www.epmmagazine.com/opinion/challenging-scale-how-to-deploy-multiple-connected-national-/ Wed, 17 May 2017 14:00:00 -0000 Challenging scale Lini Subin Lini Subin, director — regulatory affairs, ELC Group, highlights EMA’s regulatory tools and support pathways that are available during development. https://www.epmmagazine.com/opinion/early-access-to-medicines-ema%E2%80%99s-regulatory-tools-and-support/ https://www.epmmagazine.com/opinion/early-access-to-medicines-ema%E2%80%99s-regulatory-tools-and-support/ Wed, 17 May 2017 09:00:00 -0000 Early access to medicines Camargo Pharmaceutical Services has appointed Marc Wiles, Ph.D., as vice president, scientific and regulatory affairs, and Suzanne Beck, J.D., M.P.H., as director, contracts and legal projects. https://www.epmmagazine.com/news/camargo-adds-to-team/ https://www.epmmagazine.com/news/camargo-adds-to-team/ Tue, 16 Jun 2015 13:39:00 -0000 clinical development.jpg Regulatory affairs services provider ELC Group has signed up for the early-stage development of a novel vaccine targeting prevention of influenza, signalling the organisation's entry into the pharmaceutical development market. https://www.epmmagazine.com/news/influenza-project-elc-group/ https://www.epmmagazine.com/news/influenza-project-elc-group/ Tue, 16 Jun 2015 10:19:00 -0000 Influenza vaccine Regulatory affairs services provider ELC Group is expanding into the pharmaceutical development market with the creation of an extensive product portfolio targeting a range of therapeutic areas. https://www.epmmagazine.com/news/elc-group-expands/ https://www.epmmagazine.com/news/elc-group-expands/ Thu, 11 Jun 2015 11:00:00 -0000 shutterstock_70250746.jpg Professor Sam Salek at the University of Hertfordshire has published a book for global regulatory agencies and the pharmaceutical industry to use when weighing up the benefits versus risks of bringing new medicines to market. https://www.epmmagazine.com/news/universal-framework-for-new-meds/ https://www.epmmagazine.com/news/universal-framework-for-new-meds/ Mon, 01 Jun 2015 10:06:00 -0000 Uni of Herts