DIA’s Post

This year we will provide a distinct focus on addressing challenges and creating efficiencies. Delegates have the opportunity to engage with experts to exchange ideas that drive solutions for pragmatic implementation. Here’s a snapshot of the top sessions at this year’s event: ✔️Article 117 of the MDR - Where are we now? ✔️Rule 14 of the MDR - How have changes been managed? ✔️Rule 21 of the MDR - Aspects of the Consultation ✔️New EU General Pharmaceutical Legislation: How will it influence Combination Products and Diagnostics? ✔️Variations on Combination Products - Updates and the latest EMA guidance ✔️Updates on COMBINE for Combination Products and Diagnostics Plus, new this year, the event will also feature a preconference workshop on 27 January focused on Introduction to Combination Products in the EU: Regulatory and Practical Insights (separate fee required). Regulatory Affairs Professionals Society (RAPS) Register today: https://bit.ly/3YQak2c.

This year we will provide a distinct focus on addressing challenges and creating efficiencies. Delegates have the opportunity to engage with experts to exchange ideas that drive solutions for pragmatic implementation. Here’s a snapshot of the top sessions at this year’s event: ✔️Article 117 of the MDR - Where are we now? ✔️Rule 14 of the MDR - How have changes been managed? ✔️Rule 21 of the MDR - Aspects of the Consultation ✔️New EU General Pharmaceutical Legislation: How will it influence Combination Products and Diagnostics? ✔️Variations on Combination Products - Updates and the latest EMA guidance ✔️Updates on COMBINE for Combination Products and Diagnostics Plus, new this year, the event will also feature a preconference workshop on 27 January focused on Introduction to Combination Products in the EU: Regulatory and Practical Insights (separate fee required). Register today: https://hubs.la/Q02Z_xsT0

The European Commission’s proposed revision to the EU pharmaceutical legislation has taken another step forward after the European Parliament adopted its position on the draft text, which includes a seven and a half year baseline regulatory data protection period. https://lnkd.in/ePqciFCV #eu #euparliament #pharma #pharmalegistation

Regulatory Affairs Professionals Society (RAPS) and DIA are counting down to 28-29 January when we will gather in Brussels, Belgium. We are excited to meet up with global regulators, health authorities, notified bodies and industry partners. Here are just some of the topics to be discussed in Brussels this January: ✳️ Article 117 of the MDR - Where are we now? ✳️ Rule 14 of the MDR - How have changes been managed? ✳️ Rule 21 of the MDR - Aspects of the Consultation ✳️ New EU General Pharmaceutical Legislation: How will it influence Combination Products and Diagnostics? ✳️ Variations on Combination Products - Updates and the latest EMA guidance ✳️ Updates on COMBINE for Combination Products and Diagnostics View more topics and get registered today: https://bit.ly/3YQak2c.

Remote Regulatory Assessment Conducted for Industry Guidance by FDA Considering the COVID-19 pandemic, the Food and Drug Administration (FDA) has introduced new guidelines and regulations to adapt to the changing landscape of the pharmaceutical industry. One significant development is the remote regulatory assessment (RRA) conducted for industry guidance by the FDA. This approach allows for conducting regulatory assessments remotely. This will result in [Read more at the following link]: https://lnkd.in/ecpj6Jrg

The definition of Unmet Medical Need (UMN) is a provision in the EU Pharmaceutical Legislation. Are you prepared for the implications? DIA Europe 2024 tackled this question in a session now available on-demand for FREE! This session dives into the UMN concept, exploring current perspectives, proposed new definitions from the revised legislation, and future challenges and opportunities. Gain valuable insights to stay ahead of the curve in your regulatory strategy. Watch it today: https://bit.ly/4fblkgY. Looking for more? Mark your calendars for DIA Europe 2025! Stay tuned for updates and check out our website for more information: https://bit.ly/3LmbH19. #DIAEurope #RegulatoryStrategy #UMN #UnmetMedicalNeed #PharmaRegulation

As the pharmaceutical industry faces increasing pressure from generic competition and regulatory demands, mastering product life cycle management becomes essential for continuous growth and securing long-term success. Based on the current EU regulatory legislation and guidelines learn how to navigate, and register for our Product life cycle activities course on March 10-12, 2025. https://lnkd.in/dvUy3-xZ

📣💻 Last day to register for our digital session "Access Consortium and work-sharing procedures: when and how to use it?" | Zwiers Regulatory Consultancy BV Webinar Registering your product in ACCESS countries? Find out how to streamline your regulatory submissions through Access Consortium work-sharing, direct submissions to regulators, and other international collaborations with the guidance of Martina Benčan, our Pharmaceutical Regulatory Affairs Consultant. 📆 March 26, 3PM CET 🔗 Register here: https://lnkd.in/dKSYYDi3 #webinar #accessconsortium #regulatoryaffairs #regulatorysubmissions #pharma #lifesciences #worksharing

🔎 Check out this Regulatory Focus article from RAPS on the Remote Regulatory Assessments (RRAs) talks from Day 2 of FDA's Generic Drugs Forum (GDF) 2024. 💡 Learn more by visiting: https://lnkd.in/eyCjeDjx

Navigating EU FMD requirements? FMVerify simplifies the complex. Ensure traceability, meet regulations, and secure your pharmaceutical supply chain with ease. Choose compliance, choose confidence. 💼💊 #FMVerify #EU-FMD #PharmaSolutions