Get to know the new EMA Policy 70 - a playbook for the life sciences industry
EMA Policy 70 represents a significant regulatory development in the European Union's efforts to enhance transparency within the life science industry.
With the policy now spanning the whole industry after its success during the COVID-19 vaccination development, find out what this means for you with our playbook exploring:
- What’s new in EMA Policy 70
- Who will be affected and the implications for industry stakeholders
- Clinical data publication timeline for initial MAAs
- Impact analysis including compliance, transparency, accelerated processes, plus cost and resource allocation
Access your exclusive, interactive playbook here.
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Maximizing compliance and transparency
Explore our comprehensive guide on Policy 70, offering industry stakeholders clear, actionable insights into compliance provisions. This playbook serves as an essential resource for pharmaceutical companies, CROs, regulatory bodies and healthcare providers, equipping you with the knowledge to navigate Policy 70 effectively.
From compliance timelines to the new Anonymization Report template, get equipped with the strategies to enhance data transparency and optimize operational efficiency.
Key Takeaways
Strategic actions to ensure compliance and efficiency
Adopt a proactive approach and leverage robust strategies to mee EMA Policy 70's requirements
Clearly understand and adhere to revised submission deadlines for redaction proposals.
Familiarize yourself with the structured Anonymization Report template from EMA, ensuring precise and efficient report creation.
Take advantage of EMA’s pre-submission meetings to align on Scop documents and clarify compliance queries.
Implement automated processes to manage data effectively and reduce human error during compliance exercises.
Ready to optimize your compliance strategy?
Get ahead with our expert-driven insights on navigating the ever-evolving regulatory landscape.