At Asphalion, we are excited to launch our first-ever LCM Week, a new initiative dedicated to sharing expert knowledge on key topics in Life-Cycle Management!
One of the highlights of this week will be a focused webinar titled: “Navigating the Landscape of EU Data Disclosure Procedures.”
Join Asphalion Regulatory expert Nuria García Pazos in this session designed to help pharmaceutical companies better understand and manage EU data transparency requirements. This webinar will cover the main regulatory processes impacting Marketing Authorization Holders and Clinical Trial Sponsors, offering practical insights to support your compliance strategies and optimize data disclosure practices.
The webinar will address:
EMA Policy 0070: Understand the core principles of the publication of clinical data and how they affect your documentation strategies.
EMA Policy 0043: Explore the implications of access to documents under this transparency policy and how to navigate requests effectively.
EU Clinical Trials Regulation (536/2014): Learn how this regulation shapes current data disclosure requirements and what sponsors must do to stay aligned.
European Public Assessment Reports (EPARs): Gain insights into the structure and role of EPARs in data transparency and stakeholder communication.
Risk Management Plans (RMPs): Understand the transparency expectations related to RMPs and how to ensure regulatory readiness.
📅 Registrations are now open! Sign up here: https://bit.ly/4jwFDar
Stay tuned for more LCM Week activities and updates!
Need support with your regulatory activities and data disclosure procedures? Contact us at: [email protected]
