An unexpected increase in demand for one of our Drug Products because of the COVID-19 forced us to an expedited site transfer. The presentation is about the interactions with different Health Authorities which are making it possible.
The presentation will address some of the practical challenges of the implementation of the new EU Clinical Trial Regulation, not only from the operational side of things (compiling the submission) but also the strategic aspects and wider program/project implications. While there is still not much experience from either the NCAs or the industry, pilot projects enable a first glance at the challenges that may be faced in the near future.
• Overview of EU CTR
• Operational challenges
• Strategic and wider program aspects
• Lessons learned so far
AIPM (Association of Innovative Pharmaceutical Manufacturers https:// aipm.hu/en) RA WG had a survey about the role of RA country representative in the future: influence of the new trends (e-RA work, outsourcing, and centralization). The presentation shows the result of this survey.
• Goal
• Method
• Result
• Conclusion
In this presentation, we will be covering current key trends and developments in the EU regulatory network which trigger sponsor initiatives in digitalization and a call for action to ensure timely preparedness.
• EMA and EU network digital strategy
• Developments in e CTD4, ePi, and EMA’s IRIS portal
• IDMP/SPOR/DADI
• Cloud-based submissions
• Drug/CDx co-development concept in Precision Medicine
• Regulation of CDx in the US and EU
Several measures are taken by pharmaceutical companies more and more to achieve sustainability goals: in addition of recycling pictograms on packs and printed advertising materials, a reduction in the volume of printed advertising materials, adoption of QR code on packs for no drugs, etc. In regards to medicines, there are discussions ongoing at the Trade Association and Health Authorities level to promote the adoption of virtual leaflets. In Europe, medicinal product information is currently available in the form of often quite long paper leaflets found in the medicine folding box. With the increasing digitalization, and in the context of the European pharma law revision, there is a growing desire to make the product information leaflet (PIL) available in a digital format. The presentation aims to stimulate a common reflection on the sustainability roadmap.
AIPM (Association of Innovative Pharmaceutical Manufacturers https:// aipm.hu/en) RA WG had a survey about the role of RA country representative in the future: influence of the new trends (e-RA work, outsourcing, and centralization). The presentation shows the result of this survey.
The presentation will address some of the practical challenges of the implementation of the new EU Clinical Trial Regulation, not only from the operational side of things (compiling the submission) but also the strategic aspects and wider program/project implications. While there is still not much experience from either the NCAs or the industry, pilot projects enable a first glance at the challenges that may be faced in the near future.
Several measures are taken by pharmaceutical companies more and more to achieve sustainability goals: in addition of recycling pictograms on packs and printed advertising materials, a reduction in the volume of printed advertising materials, adoption of QR code on packs for no drugs, etc. In regards to medicines, there are discussions ongoing at the Trade Association and Health Authorities level to promote the adoption of virtual leaflets. In Europe, medicinal product information is currently available in the form of often quite long paper leaflets found in the medicine folding box. With the increasing digitalization, and in the context of the European pharma law revision, there is a growing desire to make the product information leaflet (PIL) available in a digital format. The presentation aims to stimulate a common reflection on the sustainability roadmap.
In this presentation, we will be covering current key trends and developments in the EU regulatory network which trigger sponsor initiatives in digitalization and a call for action to ensure timely preparedness.
”I really enjoyed learning from highly relevant presentations and lively discussions, and I will be definitely very happy to join the summit next year.
– Associate Director Global Regulatory Affairs, Translational Medicine & Devices, Merck
Inside you will find
