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The importance of building regulatory
Volume 10 Issue 1

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

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 …

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European commission review of
Volume 10 Issue 1

European Commission Review of SPC Legislation and Bolar Exemption

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 …

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Dealing with medical device regulations
Volume 10 Issue 1

Dealing with Medical Device Regulations

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 …

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Drug regulatory requirements in Bhutan
Volume 10 Issue 1

Drug Regulatory Requirements in Bhutan: A Glance

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), …

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Ireland's medtech success story
Volume 10 Issue 1

Ireland’s Medtech Success Story

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 …

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Emerging treatment, peptide receptor radionuclide
Volume 10 Issue 1

Emerging Treatment, Peptide Receptor Radionuclide Therapy, Provides New Treatment Option for Gastroenteropancreatic Neuroendocrine Tumours

With nuclear medicine therapeutics expected to represent 60% of the projected $26 billion global molecular nuclear medicine market by 2030, new alternative treatments are now …

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An update on pulmonary drug delivery
Volume 10 Issue 1

An Update on Pulmonary Drug Delivery of Dry Powders

Inhalation of air is a vital process for all human life. Inhalation for drug delivery has been established as an effective delivery method of active …

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MALDI imaging at high speed
Volume 10 Issue 1

MALDI Imaging at High Speed

Over the last decades, MALDI-TOF mass spectrometry (Matrix-Assisted Laser Desorption/Ionisation Time of Flight) has proven its usefulness and robustness in many applications, helping life scientists …

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Key challenges of bringing new drug
Volume 10 Issue 1

Key Challenges of Bringing New Drug Delivery Devices to Market

There are many challenges in bringing a good new product to market, from correctly identifying the right commercial opportunity and establishing appropriate input requirements, to …

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Successful adoption of eConsent
Volume 10 Issue 1

Successful Adoption of eConsent Best Practices for Integrating eConsent Technology

Research sponsors and investigative sites are continuing to explore the use of electronic informed consent (eConsent) in today’s clinical trials. eConsent utilises electronic systems and …

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