The Importance of Building Regulatory Competencies to Address a Broadening Skills Gap

Apr 12, 2018

The regulatory profession is a relatively new profession, having been established just a few decades ago, and people still tend to enter the field from other related disciplines. The regulatory workforce broadly includes either those who possess plenty of experience, having performed roles in other areas of the pharma sector, or graduates and younger recruits who simply enter the industry from other career fields. In order to address the skills gap, Matthew Clark of the Regulatory Affairs Professionals Society (RAPS) explains that there is a real need for formal training and certification to become standard practice for regulatory professionals. ...

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European Commission Review of SPC Legislation and Bolar Exemption

Apr 12, 2018

The SPC regulation was introduced 25 years ago and has resulted in a complex landscape of national case law and numerous decisions from the Court of Justice of the European Union (CJEU) regarding its interpretation. This article by Marie-Louise Jardle and Mike Nelson of HGF highlights the complexity of exclusivity for medicinal products in Europe and illustrates challenges faced by the EC in seeking a fair balance which stimulates innovation and the development of new medicines with the growing costs of healthcare in Europe. ...

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Dealing with Medical Device Regulations

Apr 12, 2018

In 2008, the European Commission initiated a public consultation on existing requirements covering medical devices, which produced more than 200 comments and proposals for change from a wide variety of stakeholders. As a result, the European Commission released, in 2012, its plan to restructure the EU’s medical device regulatory framework, along with a regulation that would replace existing directives for medical devices and active implantable medical devices. In this article, Richard Poate from TUV SUD explains the need to comply with the latest regulatory requirements, or risk products being withdrawn from the market. ...

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Drug Regulatory Requirements in Bhutan: A Glance

Apr 12, 2018

With the participation of officials from the Ministry of Health in international conferences on pharmaceutical safety and the International Conference of Drug Regulatory Authorities (ICDRA), Bhutan recognised the need to introduce a National Drug Policy and Medicines Legislation. Regulatory procedures have been developed to ensure promotional activities of medicines are fair, balanced, and aimed at rational drug use. Bhutan is a fast-emerging market. This article by Mr Balamuralidhara, Kaushik Devaraju, Prof. Pramod Kumar and Dr Gaurav Mathur of JSS College gives you an outline of drug regulatory requirements for registration of new drugs and other classifications of medicine of Bhutan. ...

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Ireland’s Medtech Success Story

Apr 12, 2018

Ireland’s medtech sector is internationally recognised as a leading global cluster characterised by a deeply evolved ecosystem, encompassing leading multinationals, specialised research and clinical capabilities and a dynamic start-up and indigenous base. In this article, Sheila O’Loughlin from Enterprise Ireland explains how it is that an island of just over 4.7 million people emerged as one of the world’s top five medical technology hubs over the last 20 years, rivalling key clusters such as Minnesota and Massachusetts. ...

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