Regulatory Insights

  1. Thinking Pragmatically About The Future Of Real World Evidence
    6/20/2018

    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.

  2. Regulatory Requirements For Medical Devices In China
    4/24/2018

    Successful regulatory approval requires a deep understanding of the regulations, process and technical standards, as well as an appropriate regulatory strategy.

  3. Can Your Clinical Supply Chain Pass The Brexit Pressure Test?
    3/13/2018

    - 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

  4. Twin Revolutions: Will New Tech Get Along With New Regulations In Clinical Research Technology?
    2/15/2018

    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?

  5. Insights Into Medical Device Regulations From MAGI 2017 West
    12/19/2017

    Regulatory experts outline some of the regulatory changes on the horizon for the medical device industry.

  6. Japanese Sponsor Sources Partner For End-To-End Pharmacovigilance Case Processing
    11/29/2017

    Long-standing global relationship and history of quality important factors in selecting their partner to process foreign cases for PMDA submission for studies.

  7. Regulatory Change Is Coming in the EU – Will You Be Ready?
    10/18/2017

    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.

  8. Do THIS To Shorten Your Clinical Trial
    10/3/2017

    With sponsors facing increasing pressure to reduce drug prices and bring therapies to patients faster, follow these tips to shorten your clinical development process.

  9. 10 Things To Remember About The QP Role And Process
    9/19/2017

    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.

  10. Top Brexit Questions Asked by Clinical Supply Professionals at the 2017 Sherpa Summer Seminar
    8/30/2017

    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.