Welcome to Freyr’s Regulatory Radio - a set of podcasts for all things related to Life Sciences regulations. Our one-of-a-kind Regulatory podcast series strives to simplify through candid conversations with our experts the complex positioning of pharmaceutical regulations. Essential listening for Regulatory Affairs professionals involved with strategy, submissions, and operations.
In the first season, we will discuss how a Regulatory pathway can be drafted for Europe, a region that pioneered in the setting of benchmarks for Life Sciences regulations worldwide - and continues to do so. We aim to provide a Regulatory roadmap for the European Medicine Regulatory Network (EMRN) through some insightful conversations.
Introduction to the European Medicines Regulatory Network (EMRN) across various functions and procedures. Our experts give an overview of different approval pathways and their significance and elaborate on the different networks available within EMRN for drug approvals.
Different approval pathways can be explored while entering the European pharmaceutical market. Our experts discuss the most explored approval pathways for product approval, CP and DCP, within the European Union (EU).
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Drug development takes decades of planning and experimentation. Different phases of the drug development lifecycle come with their own unique challenges. Phase-by-phase development of a drug molecule ensures that safe and effective medicines enter the patient population. Our experts talk about the phases of the drug development lifecycle from the very initial phase to the end, with a view of simplifying the complex stages of drug development.
Grant of marketing authorizations signals the commencement of the years-long journey of a drug molecule. Post-market authorization activities begin once the molecule has been approved and is fit to use for the patient population. Inspection of a given drug product is of prime importance to keep patient safety at the very core. Our experts express their views regarding monitoring medicines and the supervisory committee within the EMRN.
Time-to-market plays a major role in addressing the needs of vulnerable patient groups. Facilitated pathways across the globe accelerate the timelines of innovative drug molecules, allowing fast-tracked approval pathways for essential medicines. Our experts address the necessary requirements of innovators and elaborate on the facilitated Regulatory pathways.
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Health Authorities have accomplished major milestones in the previous decades. Fast-tracked approval of necessary medical products during the pandemic has set a benchmark for Regulatory Authorities to deliver safe and carefully examined medicines to the general population. Such efforts have set into motion a cascade of innovation and experimentation in the future of regulations and compliance. Our experts discuss diverse possibilities and innovations in the Regulatory life sciences space.
Senior Vice President, Freyr
Michael has forty (40) years of experience in the industry. He has worked predominantly in CMC Regulatory functions for twenty-nine (29) years and another eleven (11) years in other scientific development roles (formulation development, analytical method development, and clinical trials supply) at Eli Lilly and Johnson & Johnson. His experience includes managing collaborations with Regulatory partner companies. With extensive experience, he is currently leading a range of Regulatory programs at Freyr.
Senior Director for RIMS, Freyr
Gabriel has comprehensive expertise in strategic delivery, business improvement, and operational transformation and has over twenty (20) years of professional experience in various regulated industries. Gabriel is specialized in Regulatory operational improvement, health-related informatics and has worked with both the European and UK medicines Regulatory Agencies.