Home > Resource Library >
Discovery / Non-clinical
Non-clinical safety evaluation of vaccines accelerating clinical development part II
Manufacturing Chemist: Sebastian Joseph discusses regulatory expectations for the non-clinical development of vaccines
Posted:
ReadSupporting M&As in the pharmaceutical/biopharmaceutical industry
Manufacturing Chemist: At PharmaLex, we believe we have a unique understanding of the cultural challenges experienced during M&As. Having merged ourselves in 2017 into PharmaLex, we have insight in how to overcome the challenges of maintaining agility while benefiting from working in a bigger corporate environment, having economies of scale with an increased resource pool.
Posted:
ReadTogether Beyond COVID-19
PharmaLex.perts Jürgen Hönig and Lisa Pascoe discuss the challenges COVID-19 has placed on the pharma industry – from R&D to clinical trials and manufacturing to drug safety – and how companies like PharmaLex are working together with the industry to ensure regulatory compliance.
Posted:
ReadIs 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
Posted:
ReadBrexit 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
Posted:
ReadThe 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*
Posted:
ReadThe 5 things you want to know about Artificial Intelligence
PharmaLex CEO, Tilo Netzer explains the five things you should know about Artificial Intelligence
Posted:
ReadClinical Development
Non-clinical safety evaluation of vaccines accelerating clinical development part II
Manufacturing Chemist: Sebastian Joseph discusses regulatory expectations for the non-clinical development of vaccines
Posted:
ReadSupporting M&As in the pharmaceutical/biopharmaceutical industry
Manufacturing Chemist: At PharmaLex, we believe we have a unique understanding of the cultural challenges experienced during M&As. Having merged ourselves in 2017 into PharmaLex, we have insight in how to overcome the challenges of maintaining agility while benefiting from working in a bigger corporate environment, having economies of scale with an increased resource pool.
Posted:
ReadTogether Beyond COVID-19
PharmaLex.perts Jürgen Hönig and Lisa Pascoe discuss the challenges COVID-19 has placed on the pharma industry – from R&D to clinical trials and manufacturing to drug safety – and how companies like PharmaLex are working together with the industry to ensure regulatory compliance.
Posted:
ReadDrug Development Decisions
Zeb Younes & Zaklina Buljovcic will give you insightful information about new approaches to Drug Development. This article is taken from the European Biopharmaceutical Review October 2019, pages 58-64. © Samedan Ltd.
Posted:
ReadThe 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
Posted:
ReadEPR - 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
Posted:
ReadSpot 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.
Posted:
ReadIs 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
Posted:
ReadRegulatory intelligence – from knowledge to added value
Dr. Jürgen Hönig and Rob Williams look into the benefits of having the right information.
Posted:
ReadBrexit 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
Posted:
ReadArtificial 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
Posted:
ReadArtificial 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
Posted:
ReadThe 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*
Posted:
ReadThe 5 things you want to know about Artificial Intelligence
PharmaLex CEO, Tilo Netzer explains the five things you should know about Artificial Intelligence
Posted:
ReadPost-approval / Maintenance
Can a robust QMS help you achieve customer satisfaction?
PharmaLex.pert Limaris Alvarado discusses the part quality management systems (QMS) play in ensuring companies continually enhance customers’ experience and satisfaction?
Posted:
ReadProduct Launch
PharmaLex.pert Limaris Alvarado discusses the complexities of product launch and the importance of effective planning, efficient manufacturing process, technical capability, regulatory strategy, and committed launch date strategy.
Posted:
ReadTogether Beyond COVID-19
PharmaLex.perts Jürgen Hönig and Lisa Pascoe discuss the challenges COVID-19 has placed on the pharma industry – from R&D to clinical trials and manufacturing to drug safety – and how companies like PharmaLex are working together with the industry to ensure regulatory compliance.
Posted:
ReadComplying Confidently? Learning Lessons from Nitrosamine Impurities
PharmaLex.pert Diego Martinez discusses why industry must never become complacent about the safety of drug products and should seek to continually perform surveillance even if the drug is well-established.
Posted:
ReadSpot 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.
Posted:
ReadIs 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
Posted:
ReadEMA 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.
Posted:
ReadBrexit 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
Posted:
ReadThe 5 things you want to know about Artificial Intelligence
PharmaLex CEO, Tilo Netzer explains the five things you should know about Artificial Intelligence
Posted:
Read