Data Collection in Continued and Early Access Programs: Value and Utility vs. Challenges;, Upcoming Webinar Hosted by Xtalks
TORONTO, Oct. 24, 2023 /PRNewswire-PRWeb/ -- Data collection opportunities within continued and early access programs can vary significantly by country. Within a country, there also may be different regulatory pathways to pursue. Most non-clinical trial pathways for access require or allow safety data collection by the manufacturer; however, guidance on acceptable effectiveness or health outcomes data collection is limited. Many also eliminate the requirements for protocol, patient informed consent and ethics committee approval, which are necessary elements for data collection, thus limiting the ability to collect data.
- Attendees will learn about the impact of varying global regulations on data collection and the additional complexity of its operationalization.
- The featured speakers will discuss ways in which the regulatory and operational challenges may be mitigated and alternate approaches for data collection.
- TORONTO, Oct. 24, 2023 /PRNewswire-PRWeb/ -- Data collection opportunities within continued and early access programs can vary significantly by country.
- Most non-clinical trial pathways for access require or allow safety data collection by the manufacturer; however, guidance on acceptable effectiveness or health outcomes data collection is limited.