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The FDA is shifting focus to both ends of the product development spectrum
PharmaLex’s Andrew S. Verderame looks at how the FDA are introducing new measures to process and approve more complex novel and generic therapies – p52-53
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EPR - Are you giving regulatory intelligence the platform it deserves?
PharmaLex’s Jürgen Hönig and Rob Williams discuss the key elements of developing a successful knowledge-management plan – p12
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The Pink Sheet - Latin America Inches Towards Greater Regulatory Harmonization
PharmaLex’s Diego Zavala and Fatima Monterio discuss how regulatory harmonization is gathering pace in Latin America, spelling good news for pharmaceutical companies.. *subscription required*
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Is there a way of safeguarding the supply of medicines in the case of a ‘no deal’ Brexit?
The Pharmaceutical Marketing Group publishes Jonathan Trethowan’s opinion on how we can safeguard our supply of medicines in the case of ‘no deal’ Brexit
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Spot the Difference
Torben Thers Nørgaard looks at Scandinavia and how the countries have very different rules and regulations when it comes to doing business: http://www.samedanltd.com/magazine/12.
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Is there a way of safeguarding the supply of medicines in the case of a ‘no deal’ Brexit?
Jonathan Trethowan looks at how we can safeguard our supply of medicines in the case of ‘no deal’ Brexit
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The Evolving Influence of the FDA on Pharma
Andrew S. Verderame, RAC MBA shares his thoughts on the evolving influence of the FDA on pharma.
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Regulatory intelligence – from knowledge to added value
Dr. Jürgen Hönig and Rob Williams look into the benefits of having the right information.
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TOPRA // Regulatory Rapporteur Vol 15, No 10, October 2018
PharmaLex’s Tilo Netzer, Timm Pauli and Jonathan Trethowan provide their views on the number of opportunities for use of AI in clinical development and during lifecycle management of healthcare products in the latest issue of TOPRA’s Regulatory Rapporteur.
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Improving Availability of Medicines in the EU
PharmaLex Vice President Regulatory and Scientific Policy, Jonathan Trethowan discusses the EMA’s Heads of Medicines Agency (HMA) two-year work program on improving medicines supply in the EU.
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EMA simplifies the process for internal transfer of MAs
PharmaLex Vice President Regulatory and Scientific Policy, Jonathan Trethowan discusses how the EMA’s simplified process for internal transfer of marketing authorizations may help some Brexit Impacted MAHs.
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Brexit Uncertainty - impact on medicines supply
PharmaLex Vice President Regulatory and Scientific Policy, Jonathan Trethowan looks at what impact Brexit might have on medicines supply across the EU
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Artificial Intelligence in drug development: What are current use cases? - Part 2: Pharmacovigilance
PharmaLex CEO, Tilo Netzer looks at the opportunities for AI in drug development, examining the use cases in relation to pharmacovigilance
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pharmaphorum: deepdive - Digitally Transforming Pharma’s Regulatory Processes
In the latest issue of pharmaphorum’s deepdive: Future Pharma 2018, Rob Williams and Timm Pauli discuss Digitally Transforming Pharma’s Regulatory Processes
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Artificial Intelligence in drug development: What are current use cases? - Part 1: Regulatory Affairs
PharmaLex CEO, Tilo Netzer looks at the opportunities for AI in drug development, examining the use cases in relation to regulatory affairs
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The Pink Sheet - Big Data: Moving From Artificial Trials To A Smarter Regulatory Process
PharmaLex’s Bruno Boulanger discusses the impact big data will have on how the pharmaceutical industry gathers and delivers data in the future. *subscription required*
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The 5 things you want to know about Artificial Intelligence
PharmaLex CEO, Tilo Netzer explains the five things you should know about Artificial Intelligence
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