Author: Dr Anika Schröter
The development of RNA-based drugs has increased within the past years and is a promising field of research in the pharmaceutical industry. It is transforming the industry and will offer new hope for patients with unmet medical needs.
RNA-based drugs have several advantages over conventional drugs, such as the ability to target previously undruggable pathways, the rapid and cost-effective development, and the potential for personalized medicine. However, RNA-based drugs also face some challenges, such as the stability, delivery, and safety of the RNA molecules.
This whitepaper informs about the challenges with the 'standard' non-clinical program for different RNA-based drugs, focusing on safety evaluation.
Download now the white paper 'Non-clinical aspects of RNA-based drug development'.
We hope you enjoy reading it!
Our global and local experts will update you every two months with the latest regulatory and legislative developments. Thus, you will always have the essential information and trends in regulatory affairs at your fingertips!
Explore how recent U.S. pharmaceutical pricing reforms may impact the European pharma sector. This online seminar provides a transatlantic perspective on policy trends, trade risks, and pricing dynamics.
Regulatory expectations regarding risk management for pharmaceuticals in (emerging) markets often contend with the stringent standards set by the EU/ICH regions. Join us in five consecutive webcasts to gain insights into local pharmacovigilance systems in different countries and regions, and learn how to integrate them into your global PV system while maintaining a clear overview!
Our experienced speakers will help you prepare for all the challenges facing board members in German banks.
Our experienced speakers will help you prepare for all the challenges that supervisory boards face.
This online course shall provide a sound overview about different local laws in important countries in EU and beyond with respect to employee invention rights. It shall enable the participants to address complex situations when designing and negotiating agreements for cross-border R&D.
This seminar provides a comprehensive overview of RIM and IDMP requirements, system challenges and best practices. It also explores the role of AI, cloud solutions and future trends in regulatory information management. Participants will gain practical insights to optimise processes and prepare for upcoming regulatory developments.
The conference will cover recent updates and practical implications of the EU pharmaceutical legislation, the application of AI in RA, and the new EU Variation regulation. Additionally, it will address the latest developments in quality (draft) guidelines: ICH M13a and M13B, ICH M4Q(R2), EU GMP Annex 11, New Annex 22 on AI, and an update on the ongoing discussions on nitrosamine "contaminations".
We will focus on how to integrate compliance and governance into Medical Affairs activities and ensure quality documentation that is both effective and pragmatic.
This course offers a deep dive into patient involvement in HTA processes across Europe, with a focus on the UK and Germany - learn practical approaches, regulatory insights, and how to engage meaningfully with patient organisations.
The seminar covers essential topics such as stakeholder identification, effective meeting preparation, and legally compliant collaboration. Tailored for Medical Science Liaisons (MSLs) and Medical Affairs teams, the seminar equips you to gain real insights from KOLs, overcome challenging situations, and elevate patient outcomes.