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The https://www.direnzo.biz podcast for pharmaceutical companies, for manufacturers of medical devices, cosmetics, food supplements and disinfectants. News from our blog and from our weekly magazine ISI, Information Health.
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The Di Renzo Regulatory Affairs podcast for pharmaceutical companies, for manufacturers of medical devices, cosmetics, food supplements and disinfectants. News from our blog and from our weekly magazine ISI, Information Health.
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Episodes & Posts
Episodes
Posts
24 JAN 2025 · 🎙 New Podcast Episode: Clinical Trials and the New GCP E6(R3) Guidelines
💊 Clinical trials are a cornerstone of developing safe and effective therapies, ensuring compliance with ethical and scientific standards.
But how is this process evolving with the latest regulatory innovations? In this episode, we delve into the updates introduced by the Guideline for Good Clinical Practice (GCP) E6(R3), published by the International Council for Harmonisation (ICH) on January 6, 2025. 🔍 Topics include:
- Key updates compared to the previous E6(R2) version.
- How these changes enhance the quality and efficiency of clinical trials.
- The impact of new technologies on clinical research.
- The role of EU Regulation 2014/536 in ensuring regulatory harmonization across Europe.
💡 This episode is tailored for professionals and companies in the pharmaceutical sector who want to stay up-to-date with the latest developments and regulations in clinical research. 📲 Listen now to learn more: https://www.direnzo.biz/it/en/drug-clinical-trials/ Don’t miss this opportunity to explore a critical topic shaping the future of research and therapeutic development! 🌍
17 JAN 2025 · 🎙 New episode of our podcast!
In this episode, we discuss the https://www.direnzo.biz/it/en/professional-drug-sector/. We analyze how transformations in the industry, driven by technological innovation and increasingly complex regulations, are creating opportunities for unique and highly specialized roles.
What are the most in-demand skills?
How is the job market evolving in the pharmaceutical field?If you’re interested in exploring the new frontiers of this industry and discovering career opportunities in this field, this episode is a must-listen!
Tune in now and find out how the pharmaceutical sector is reshaping the job market.
7 JAN 2025 · This episode of the podcast is tailored for pharmaceutical companies planning to organize meetings, conferences, or scientific events, both in Italy and abroad.
We’ll delve into the key regulations and compliance requirements that must be met, with a particular focus on events related to the promotion of medicinal products manufactured or marketed by the same company.
In Italy, the law establishes specific procedures to ensure transparency and integrity, preventing conflicts of interest and safeguarding the quality of disseminated information. Among these is the obligation to obtain prior authorization from the Italian Medicines Agency (AIFA), which must be requested at least 60 days before the event begins, as outlined in Article 124 of Legislative Decree 219/06.
If your company is planning a scientific event, this episode will guide you through the requirements and steps necessary to ensure regulatory compliance.
14 NOV 2024 · The Importance of Article 16 of the MDR
Article 16 represents a major advancement in the https://www.direnzo.biz/it/en/parallel-imports-medical-devices/, providing more clarity and detail than previous regulations. Specifically, it:
- Clearly defines what constitutes a parallel import of a medical device.
- Underscores the critical importance of adherence to essential requirements and harmonized standards.
- Imposes specific obligations on parallel importers, including verification of technical documentation and device traceability.
- Allows for corrective and safety measures to be taken in the event of non-compliance.
7 NOV 2024 · In this episode, we delve into the crucial role of the https://www.direnzo.biz/it/en/qppv-task-responsibilities/ (QPPV). We'll explore their responsibilities, qualifications, and the importance of their role in ensuring patient safety. From setting up pharmacovigilance systems to managing risk assessments and responding to regulatory inquiries, the QPPV plays a pivotal role in the post-marketing surveillance of medications.
22 JUL 2024 · Welcome to the new Di Renzo Regulatory Affairs podcast!In the ever-evolving landscape of medical device regulation, it is crucial to stay up-to-date. That's why today we'll delve into Regulation (EU) 2023/607, a significant amendment to https://www.direnzo.biz/it/en/mdd-mdr-medical-devices-class-i/ that introduces an extension of the transition period and defines the criteria for benefiting from it.As Regulatory Affairs experts dedicated to Class I medical devices, Di Renzo Regulatory Affairs is ready to support manufacturers in this delicate transition process.In this podcast, we will guide you through the details of Regulation 2023/607, clarifying:
- Which Class I medical devices are eligible for the extension
- How to correctly assess the classification of your device
- What are the specific timelines for the extension
- How to make the most of this additional period to prepare for the MDR
By listening to this podcast, you will gain the knowledge you need to confidently navigate the new regulations and plan a smooth and efficient transition to the MDR.Stay tuned to discover how Di Renzo Regulatory Affairs can support your success in the new medical device regulatory framework!Here are some additional points that you may want to include in your podcast intro:
- Introduce Di Renzo Regulatory Affairs and its expertise in medical device regulation.
- Highlight the importance of the MDR and its impact on Class I medical device manufacturers.
- Emphasize the value of Di Renzo Regulatory Affairs' services in helping manufacturers comply with the MDR.
- Encourage listeners to subscribe to the podcast and leave reviews.
I hope this is helpful!
The https://www.direnzo.biz podcast for pharmaceutical companies, for manufacturers of medical devices, cosmetics, food supplements and disinfectants. News from our blog and from our weekly magazine ISI, Information Health.
show more
The Di Renzo Regulatory Affairs podcast for pharmaceutical companies, for manufacturers of medical devices, cosmetics, food supplements and disinfectants. News from our blog and from our weekly magazine ISI, Information Health.
show less
Information
| Author | Di Renzo Regulatory Affairs |
| Organization | Di Renzo |
| Categories | Entrepreneurship |
| Website | www.direnzo.biz |
| info@direnzo.biz |
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