All Regulatory affairs articles
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InterviewHow to inspire a new generation of regulatory professionals
Kate Betteridge, Global Regulatory Portfolio Lead at Pfizer, and winner of the ‘Inspiration’ award at the 2024 TOPRA Awards for Regulatory Excellence, discusses strategies for harnessing innovation and creativity and her role in developing the regulatory professionals of the future.
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InterviewHow to develop your skills and stand out from the crowd
Michelle Blake, Associate Director and Senior Regulatory Consultant at DLRC Ltd, and winner of the ‘Contribution’ award at the 2024 TOPRA Awards for Regulatory Excellence, discusses her career path in regulatory affairs and gives advice on how to develop your skills and go that extra mile.
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JournalA comprehensive analysis of drug pricing mechanisms and the regulatory framework in Morocco
Access to affordable medication is crucial for equitable healthcare systems, but balancing drug pricing and accessibility is challenging. Unaffordable drug prices are a global concern, affecting high-, middle- and low-income countries alike. Understanding drug pricing mechanisms in Morocco is essential for ensuring equitable healthcare access and system sustainability. This article provides a review of pharmaceutical pricing and reimbursement policies in Morocco, traces the historical evolution of drug pricing mechanisms, and explains their role in the drug registration process.
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JournalThe role of artificial intelligence in regulatory affairs
This article explores the enormous potential of artificial intelligence (AI) technologies in regulatory affairs, highlighting how AI can streamline regulatory compliance, expedite submissions, enhance predictive analytics for decision-making, improve pharmacovigilance and elevate regulatory intelligence when properly applied. The discussion covers not only the advantages of AI but also the complexities of integrating AI into regulatory affairs, such as the challenges of algorithm interpretability, data quality, regulatory compliance, fairness, security, privacy and model accuracy. Additionally, it emphasises the collaborative efforts of the global regulatory community in developing guidelines and frameworks for the safe and effective use of AI.
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JournalEnvironmental impact of pharmaceuticals and regulation in the EU
The profound impact of pharmaceuticals on the environment has been acknowledged for decades. In the EU, two key mechanisms that assess this risk are the Environmental Risk Assessment (ERA), and Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). As both frameworks are under assessment, this article looks at the key considerations within the ERA.
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Case StudyCase study: The evolving regulatory environment
Reproduced from a webinar presentation, made in collaboration with TOPRA and Roche, given on December 15 by Caroline Kuhn, François Hebraud, and Vijay Reddi, of Roche.
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