Regulatory Affairs departments in life sciences companies face an increasingly complex environment, where utilising your supporting IT systems is no longer an option, but a necessity. Taking advantage of these IT systems can open up a world of opportunities. With initiatives such as PIM, SPL and eCTD, it’s clear that the companies that are most successful in adopting these will also be the companies that stand to gain the most.

eCTD submissions by 2009

Regulatory authorities have clearly indicated that all EU member states will be able to process applications using the eCTD format by 2009 to file paperless submissions. Failing to address this will be very expensive – as it is not only about implementing technology but about changing the mindset of people working with life sciences submissions. This situation creates a clear need for improved efficiency within regulatory affairs – a need for Submission Management Excellence in Regulatory Affairs.

Invitation - View the programme here 

Morning1 presentations
Morning2 presentations
After lunch presentations
Afternoon presentations


The conference will address the following key topics:

§          Improving processes and efficiency

§          The upcoming PIM initiative from EMEA

§          The regulatory perspective on eCTD

§          XML in pharmaceuticals

§          Simultaneous global eCTD submissions

§          Extending the value of existing EDM systems

§          Collaboration in regulatory affairs

We look forward to seeing you at this Life Sciences Conference on Regulatory Affairs.