RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > Key Aspects of Pharmaceutical Due Diligence Intellectual Property Assessment—Part II

Key Aspects of Pharmaceutical Due Diligence Intellectual Property Assessment—Part II

Posted 01 November 2010

In Part I of this two part series, published in the October 2010 issue of Regulatory Focus, we discussed the importance and process of the due diligence intellectual property (IP) assessment as well as the differences in patent exclusivity in the US and EU. In Part II, we provide overviews regarding the role of the regulatory professional, patent attorney (PA) and chemistry, manufacturing and controls (CMC) professional for the IP assessment. In addition, a case study is presented to tie together the concepts discussed in Parts I and II.

 

© 2022 Regulatory Affairs Professionals Society.