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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Pharmacoepidemiology and Drug Safety

Kaplan S, Goehring Jr. EL, Melamed‐Gal S, Nguyen‐Khoa B‐A, Knebel H, Jones JK. Modafinil and the risk of cardiovascular events: Findings from three US claims databases. Pharmacoepidemiol Drug Saf. 2018;1–9.

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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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The European Journal of Contraception & Reproductive Health Care

Jones JK, Tave A, Pezzullo JC, Kardia S, Lippes J. Long-term risk of hysterectomy and ectopic pregnancy among Vietnamese women using the quinacrine hydrochloride pellet system vs. intrauterine devices or tubal ligation for contraception. Eur J Contracept Reprod Health Care. 2018 Apr;23(2):105-115.

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