Updates to EMA Policy 70 Anyone Working in Clinical Transparency and Disclosure Should Know
With the publication this past March of the EMA’s “Policy 70: External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use,” the deadline for sponsors to submit anonymized regulatory documents for publication is looming. How will you develop a process that ensures compliance with this mandate and reduces your risk of disclosing private information?
During this presentation, Lora Killian, Synchrogenix Director of Transparency and Disclosure, discussed complications caused by the requirements outlined in the guidance document:
- Study administrators’ right to privacy – who’s in and who’s out
- Re-identification risk posed by study administrator address information
- Retrospective anonymization of documents that have already been written
- Challenges with masking narratives
Ms. Killian also proposed some solutions that incorporate techniques earlier in the writing process to ease the anonymization process later in the submission timeline.