Getting Ready for the EMA Policy 0070 - Clinical Data Publication - Relaunch

Whether you’re in pharmaceuticals, regulatory affairs, or simply curious about the latest happenings in drug regulation, you need to stay informed and prepare for the relaunch of Policy 0070. In this article, we will look at the critical aspects of this policy, its aims, and the redaction process.

EMA's New Directive Proposal: Rethinking Pharmaceutical Legislation Through Environmental Risk Assessment

Take a look at how the European Medicines Agency (EMA) is revolutionizing pharmaceutical legislation to prioritize environmental responsibility.

Sunset Clause Implementation in the EU

Explore and understand the EU pharmaceutical regulations with our latest article on the Sunset Clause. The Sunset Clause ensures the continuous supply of medicinal products while maintaining quality and compliance. Both pharmaceutical professionals and regulatory enthusiasts will benefit from grasping the Sunset Clause’s impact, applicability, and exemptions, keeping patient safety at the forefront. Come and join the conversation.

Importance of Toxicology Risk Assessment of Medicines

In today’s interconnected world, the safety of consumer products across diverse industries is of utmost importance. Let us dive into the world of toxicological risk assessment and the inextricable role of regulatory authorities in securing product safety and public health.
Learn how hazard identification and thorough toxicology risk assessments form the cornerstones of consumer protection and industry standards with PLG.

European Commission unveils most significant pharma reform in 20 years

The European Commission unveiling a revolutionary pharmaceutical reform proposal on 26th April 2023 is exciting news. It has been designed to enhance patient access, affordability, and innovation. Here, we showcase the key strategies, such as tackling medicine shortages, boosting innovation in rare diseases, combating antimicrobial resistance, and promoting environmental sustainability.
It’s a must-read for healthcare and pharmaceutical professionals looking to stay ahead of the curve.

Discover our beloved employees's ambitions and feelings in PLG during our 30th Anniversary!

We want to share our employees’ thoughts and feelings about what ProductLife Group means to them and what it is like to work here. In this video, we talk about their goals and how they align with those of the company, the work-life balance, the benefits of working at PLG and the global culture they experience. Check out the video to hear their feedbacks. We are PLG!

Unlicensed "Special" Medicinal Products in the UK: A Comprehensive Overview

Unlicensed Special Medicinal Products can serve as a lifeline for patients with limited or no treatment options. Such products are governed by tight pharmacovigilance laws that require MAH, prescribers or other related parties to inform authorities of their usage or any adverse reactions. ProductLife Group, with its experts on MHRA UK regulations, provides assistance in obtaining authorization to MAH dealing in unlicensed medical products in the UK.

Nordic Countries Specific Pharmaceutical Requirements

Explore the intricate rules governing pharmaceutical regulatory affairs in the Nordic countries. Read to learn more about harmonization efforts, unique requirements, and collaborative initiatives molding the industry in these countries while understanding submission procedures, packaging, and labeling regulations in this ever-changing landscape.

Decentralized Clinical Trials for Drugs, Biological Products, and Devices

Exciting developments are taking place in the world of clinical trials. The U.S. Food and Drug Administration (FDA) is adopting decentralized clinical trials (DCTs) for drugs, biologics, and devices. This approach allows some or all trial-related activities to happen in the comfort of the participant’s home. This can broaden the amount of participation and improve accessibility, particularly for those with rare diseases or mobility challenges.

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September 2023 Monthly Newsletter