Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You or Your Team.

Learn More →

DeepDyve requires Javascript to function. Please enable Javascript on your browser to continue.

Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional

Part of the SpringerBriefs in Pharmaceutical Science & Drug Development Book Series

DOI: 10.1007/978-1-4614-3682-9

ISBN: 978-1-4614-3681-2

Publisher: Springer New York - Springer Journals

Apr 9, 2012

LitStream

Chapter 1Introduction to Competitive Intelligence

Huml, Raymond A.

Pages: 1 –38

[Pharmaceutical competitive intelligence (CI) entails defining, gathering, analyzing, and distributing intelligence—both non-proprietary and proprietary—on pharmaceutical products, customers, competitors, and any aspect of a particular functional area needed to support executives and managers in...
LitStream

Chapter 2Overall Perspective of Due Diligence Investigations and Processes

Huml, Raymond A.

Pages: 39 –41

[Risk-based transactions are rapidly becoming more popular methods of delivering innovative partnering solutions to customers. As a result, CROs and CSOs now add partnering solutions to their list of client options in addition to the more traditional, contract-awarded business transactions such...
LitStream

Chapter 3The Regulatory Functional Review: Primary Roles

Huml, Raymond A.

Pages: 43 –45

[Regulatory affairs professionals are expected to provide an overall assessment of product information in the following areas: (1) US and applicable foreign regulatory affairs; (2) preclinical information; (3) clinical information; (4) CMC and Supply Chain information; and (5) commercial...
LitStream

Chapter 4The On-Site Due Diligence/Data Room Meeting and Interactions with Other Functional Area Experts

Huml, Raymond A.

Pages: 47 –63

[Multiple tasks must be performed by the regulatory professional before the critical on-site due diligence meeting occurs in a private data room. Due diligence typically occurs in a secured data room format because the intellectual property (IP) is highly confidential, though, with the advent of...
LitStream

Chapter 5Intellectual Property

Huml, Raymond A.

Pages: 65 –74

[Because the intellectual property (IP) assessment is critical to determining the amount and length of protection that a product will have in a particular market/geography, a complete section is provided to address this important aspect of CI [1, 2].]
LitStream

Chapter 6The Final Report

Huml, Raymond A.

Pages: 75 –75

[Although every organization has its own unique process for assessing a partnering or licensing opportunity, best practice suggests that evaluation of medical technologies should include an evaluation of product, market and legal, manufacturing, and financial issues. The final due diligence...
LitStream

Chapter 7Competitive Intelligence Summary

Huml, Raymond A.

Pages: 77 –78

[If trends continue, it is highly likely that regulatory professionals will become involved in one or more aspects of a due diligence process and be tasked with the identification of competitive intelligence. They will play a major role in evaluating risk-based transactions and competitive...

results per page

Prev
1
Next

Browse All eBooks