Panel Discussion: Discussing Perspectives on Regulatory Expectations to Improve Submission Clarity & Accelerate Development Timelines
Time: 3:30 pm
day: Conference Day One
Details:
- Explore key differences in manufacturing practices for pharmaceutical vs industrial isotope use, including how processes, quality standards, and documentation are adapted for GMP compliance.
- Review common regulatory questions and challenges faced when submitting Drug Manufacturing Files (DMFs), and how these vary across agencies like the FDA and EMA.
- Discuss how to balance confidentiality with regulatory transparency, and how pharma and isotope suppliers can better align to meet submission requirements without disclosing sensitive IP.
