Freyr Regulatory Radio

Episode 5. Global & the European Facilitated Regulatory Pathways

pr@freyrsolutions.com — Mon, 02 May 2022 06:33:25 +0000

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.

Reference Links

Centre for Innovation in Regulatory Science report New drug approvals in six major authorities 2011-2020

Episode 4. Monitoring Medicines and Supervisory Committees

pr@freyrsolutions.com — Fri, 22 Apr 2022 05:45:17 +0000

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.

Episode 3. Drug Development Lifecycle & Pathways

pr@freyrsolutions.com — Wed, 13 Apr 2022 05:59:59 +0000

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.

Episode 2. Centralised and Decentralised Procedures

pr@freyrsolutions.com — Mon, 04 Apr 2022 05:25:22 +0000

Different approval pathways can be explored while entering the European pharmaceutical market. The approval pathways include:

Centralized Procedure (CP)
Decentralized Procedure (DCP)
National Procedure (NP)
Mutual Recognition Procedure (MRP)

Our experts discuss the most explored pathways, CP and DCP, and the eligibility criteria to pursue them for product approval and marketing authorization within the European Union (EU).

Reference Links

Episode 1. The European Medicines Regulatory Network

pr@freyrsolutions.com — Fri, 25 Mar 2022 04:52:21 +0000

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.