Blogs

  1. Overcoming Hurdles With A Contamination Control Strategy 7/26/2024

    Learn about the importance of a facility-specific CCS, explore common hurdles encountered in its development and get practical advice on creating a robust and compliant strategy.

  2. EU GMP Annex 1 – Navigating The Road To A Successful Annex 1 Inspection 7/17/2024

    The complexities of EU GMP Annex 1 inspections can be challenging. At an event hosted by NIBRT and Cencora PharmaLex, industry experts shared key insights and best practices for ensuring compliance.

  3. IPD: The Pathway To A Well-Planned R&D Program 7/17/2024

    IPD streamlines the journey from research to clinical application, ensuring each step is seamlessly interconnected. Discover how this approach enhances efficiency and compliance in R&D.

  4. EMA Adopts Collaborative Approach With ATMP Guideline Update 7/17/2024

    The EMA has taken a collaborative approach with its updated ATMP guideline, aiming to streamline development and clarify regulatory expectations for cell and gene therapies across Europe's landscape.

  5. Bringing A Product To Market In The EU: Key PV Considerations 7/17/2024

    Explore key considerations and strategic approaches essential for navigating the complexities of safety reporting within the European market.

  6. Preparing The PMS: A Commercial And Regulatory Imperative 7/17/2024

    Learn how proactive engagement with the Product Management Service (PMS) can pave the way for enhanced decision-making, operational agility, and sustained competitiveness in the pharmaceutical industry.

  7. Pre-Launch Checklist - A Roadmap To Success 6/21/2024

    The path from groundbreaking therapy to readily available treatment requires a strategic approach. Delve into ten critical questions that can help you chart a successful course for your CGT therapy.

  8. Vigilance Guidance Provides Greater Clarity On MDR Requirements 6/12/2024

    Explore how new vigilance guidance under MDR clarifies reporting obligations for high-risk medical devices, ensuring enhanced safety oversight and compliance amid stricter regulations.

  9. How Intuitive Decision Rules In Clinical Trials Can Support Regulatory Requirements 6/12/2024

    See how Bayesian decision rules in clinical trials can align with regulatory standards, offering intuitive and adaptive solutions amidst traditional challenges in frequentist frameworks.

  10. EMA's Concept Paper On Confirmatory Clinical Studies A Welcome Step For Industry 6/12/2024

    Explore the implications of the European Medicines Agency's Concept Paper, its potential impact on biosimilar developers, and the broader implications for the pharmaceutical industry.