Questions and concerns as the FDA prepares to develop and implement a program evaluating the potential use of Real World Evidence (RWE) for regulatory decisions.
Successful regulatory approval requires a deep understanding of the regulations, process and technical standards, as well as an appropriate regulatory strategy.
- Clinical trial sponsors and clinical supply vendors must fully consider all attributes of their supply chains to ensure continuity of supply post-Brexit. This whitepaper outlines many questions that sponsors and vendors alike should ask
What can be done to that the technology opening new doors in the capture and analysis of clinical data, and the guidance responsible for regulating them, keep up with one another?
Regulatory experts outline some of the regulatory changes on the horizon for the medical device industry.
Long-standing global relationship and history of quality important factors in selecting their partner to process foreign cases for PMDA submission for studies.
As the global reach of clinical trials has increased, and with the deadline for EU compliance quickly arriving, many in pharma are finding themselves in a dilemma.
With sponsors facing increasing pressure to reduce drug prices and bring therapies to patients faster, follow these tips to shorten your clinical development process.
The QP process is a necessary process that every sponsor company wishing to undertake trials in, or move product through the European Union must undergo. When faced with this process, many companies are unsure as to what to expect.
Based on their survey of San Diego's clinical supply community, there are a lot of concerns around Brexit's impact on clinical supply. Sherpa took the top questions asked by their Sherpa Summer Seminar audience, and answered them in this Q&A.
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