Freyr Regulatory Radio

Season 2: Episode 2 - Pharma Advertising and Promotions: Australia

Pharmaceutical advertisement in Australia is self-regulated or co-regulated, with various bodies having their codes relevant to the promotion of drugs. Our host gives a fair understanding of how the Regulatory environment can present a challenge for companies bringing new products to the market and promoting them.
Tune into other episodes of Season 2: https://www.freyrsolutions.com/regulatory-radio/season-2-pharma-advertising-and-promotions

Season 2: Episode 1 - Pharma Advertising and Promotions: Zimbabwe

A considerable grey area exists between providing information and promoting medicines in a semi-regulated market like Zimbabwe. Our host explores the pharmaceutical laws and regulations laid down by the Medicines Control Agency of Zimbabwe and elaborates on the key takeaways from the advertising legislative framework.
Tune into other episodes of Season 2: https://www.freyrsolutions.com/regulatory-radio/season-2-pharma-advertising-and-promotions

Season 2: Episode 0 - Pharma Advertising and Promotions: Introduction

Welcome to Regulatory Radio, brought to you by Freyr Solutions. In the second season, we discuss the ad promo laws and regulations, offering a consolidated and high-level understanding of the laws in regulated and semi-regulated markets. With dynamic changes in the jurisdictions, compliance with the defined laws and interpretation of the concerned Health Authorities is essential.
Advertising of drugs has been a common practice adopted by pharmaceutical organizations. To protect the public from being manipulated, the Health Authorities introduce various acts to prohibit any illegal promotions. Our host provides an overview of advertising laws and regulations across six jurisdictions.

Episode 6. Regulatory Compliance - The Future & Next Steps

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. 

Episode 5. Global & the European Facilitated Regulatory Pathways

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

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. Medicinal Products Lifecycle & Regulatory Pathways

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

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
EMA overview of the centralised authorisation procedure
European Commission summary of national authorization procedures
CMDh guidance on marketing authorization applications

Episode 1. The European Medicines Regulatory Network

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.