Webinar: Best practices for validating literature monitoring searches

In the context of literature monitoring for adverse reactions to medicinal products (EMA GVP Module VI), a reasonable number of Market Authorization Holders have no ready answer to justify why they use each search formula for each specific product when Audit or Inspection time comes: in fact the search formula, responsible for all the inbound traffic in the… Read More »

21 CFR 11 Reflections: 10(a,c,d)

When I read regulatory documents I always try to imagine what possible reason can there be for someone to write a regulation and what may have been the real world case(s) that will be prevented by that text. Sometimes it is clear that a text not only is intended to have specific consequences, but also is based on real… Read More »

SCRUM MASTER Certification @ RUMOS w/ Peter Stevens

I did the Scrum Master certification course with Peter Stevens, facilitated by the Portuguese training company RUMOS. Having recently being appointed Senior Product Development Manager at Elsevier R&D, with a strong requirement in acting as Product Owner for the relevant agile Teams, this was a must have. The course was delivered  following a SCRUM approach, ie: each module… Read More »