This edition of #ICYMI from the Acorn Regulatory archives could easily be called the ‘What?’ edition. We look at 4 articles from our archive that ask and answer important questions in regulatory affairs, quality and careers.
#ICYMI looks at articles that you might have missed from the Acorn Regulatory archives. These articles have been written by members of our rapidly growing team.
Variations are a critical part of maintaining the lifecycle of all dossiers. A variation is any change to the currently approved content of a marketing authorisation which assists in ensuring continued compliance. We look at the main types of variations and the critical issues that you need to be aware of when completing a variation. Find out more about common variation validation issues here.
Much has been written about the benefits of smart packaging for the pharmaceutical sector. The introduction of smart packaging technologies is regarded as another step in safeguarding the security of medicinal products and devices. Below, we look at smart packaging and consider the benefits that it might bring to our sector.
What We Have Learned About Work Flexibility
Now that our flurry of recruitment is (almost) over, I have had the time to look back on all of my notes and to think about the issues that arose during the many meetings that we held in Ireland and the UK with prospective employees. Despite the differences in location, qualifications, experience and other elements, there was one issue that consistently arose during the course of our conversations with candidates. That issue was the lack of opportunities for remote working or work flexibility.
According to the CMDh the ‘Repeat Use Procedure’(RUP) is the use of the Mutual Recognition Procedure (MRP) after the completion of a first MRP or Decentralised Procedure (DCP) for the recognition of a marketing authorisation by other Member States (MS).
This means that a marketing authorisation holder may use the MRP several times for the same marketing authorisation, once the first MRP is complete, to include additional member states (MS) that were not involved in the initial MRP. Read more here.
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