PharmaLex January 2025 newsletter

As we prepare for another busy year in the industry, PharmaLex encourages you to step back and review some of the biggest developments of 2024. Whether uncovering trends and innovations, industry requirements and regulations, or ways to maintain business success, our thought leaders have their fingers on the pulse of the rapidly changing life sciences industry.

Read insights from our experts

Check out our recent thought-leadership blogs and articles?to help you stay on track

1. The journey to eCTD 4.0

From its earliest steps to the latest implementation plans, eCTD 4.0 has seen many changes and developments. While the journey has taken time, eCTD 4.0 pilots are imminent. Learn more about the history of and plans for the submission standard.

2. The changing face of the local affiliate

Managing mature portfolios in global markets places a huge burden on local affiliates, which is leading many companies to consider outsourcing partners to streamline processes. Discover how regulatory demands are changing the affiliate model.

3. Quality reviews and the TMF

In preparation for an inspection, it’s important to reduce the risk of major findings with the trial master file (TMF). Learn more about quality reviews, what they are, when to perform them, and how to deal with the unknowns of an inspection.

4. How to build a smart CAPA framework

Corrective and preventive actions (CAPAs) are a requirement for demonstrating a robust quality management system (QMS) but also a significant business benefit. Find out how to build a solid and achievable CAPA framework.

5. Overcoming barriers to EU combined studies

Lack of regulatory alignment has created challenges for combined studies – medicinal products with IVDs/medical devices. Learn more about the COMBINE project in Europe and how it proposes to tackle the challenges facing sponsors.

Hear what our experts are discussing

Dive into thought-provoking discussions and stay ahead with our latest insights.

1. Unlock the secrets to managing the CTR

The Clinical Trial Regulation (CTR) has left many in industry concerned about how to navigate its intricacies. Listen to our expert team as they explore how to manage the EU’s clinical development arena and case studies for tackling challenges.

2. How technologies are transforming pharmacovigilance

New technologies are making processes such as safety reporting far easier and more accurate. Hear the panel of experts discuss the promise and the business challenges to adopting new technologies as well as use cases with outcomes and lessons learned. ?

3. TMF Inspection readiness

What are inspectors looking for? What trends are inspectors seeing with the TMF? And what can you do to get ready for when the inspectors are expected? Join our TMF expert to learn more about just in time preparation for a TMF inspection.

4. Alternative Submission Pathways

Two submission pathways are emerging as ways to enhance collaboration among health authorities and facilitate more efficient approval processes for new medicines. Discover more about the Access Consortium and Project Orbis.

5. Driving Product Launch Success in Europe

Companies must overcome regulatory and supply chain hurdles to launch a medicinal product in Europe. Learn how to effectively plan and execute a successful market launch and gain practical insights from a real-world case study.

We look forward to providing you with more industry insights this year!?

This newsletter is intended to communicate PharmaLex's capabilities which are backed by the authors’ expertise. However, PharmaLex and its parent, Cencora, Inc., strongly encourage readers to review the references provided and all available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions related thereto as the information provided may contain certain marketing statements and does not constitute legal advice.