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 »
Question on a LinkedIn group: V model for Agile? Life Science industry is using traditional V model for CSV. Should this model be changed for Agile based development, testing and validation. I believe we should be able to use the user stories instead URS as the basis of V model. Please share your thought. Thanks PJ Singh, PMP… Read More »
The question: “Where do you see yourself in 5 years? ” does not make any sense. I hope your offer is interesting enough so that my job description, 5 years from now, will include several tasks and competencies that do not even exist today. And that is where I see myself in 5 years, in your company: Doing… Read More »
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 »
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 »
This blog, probably, wont last long… but here it goes.