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

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Supporting 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.

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Together 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.

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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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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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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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Clinical 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

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Supporting 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:

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Together 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.

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Drug 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.

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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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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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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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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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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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Authorization / Approval

Successful marketing of medicinal cannabis and cannabis derived products

International Pharmaceutical Industry: Barbara Siebertz and Ute Hegener look at the national legal requirements of some European countries on medicinal cannabis, while highlighting the differences within the EU.

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Improving the chances of EU approval

International Clinical Trials: Improving the chances of EU approval – Lisa Pascoe and Lucy Gluyas discuss the steps required to ensure a successful Clinical Trial Application (CTA)

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Successful marketing of medicinal cannabis and cannabis-derived products part I

Nutraceutical Business Review: Barbara Siebertz and Ute Hegener discuss the current legal and marketing situation in Europe

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Successful marketing of medicinal cannabis and cannabis-derived products part II

Nutraceutical Business Review: Barbara Siebertz and Ute Hegener discuss the current legal and marketing situation in Europe

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Successful marketing of medicinal cannabis and cannabis-derived products

Teknoscienze – Chemistry Today: Barbara Siebertz and Ute Hegener look at the national legal requirements of some European countries on medicinal cannabis, while highlighting the differences within the EU.

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Together 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.

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Quality Investigations & CAPAs "Elementary, my dear Watson"​

PharmaLex.pert Gerado Gomez discusses the importance of Quality and Complaint Investigations and CAPA Management

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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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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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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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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 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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Post-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?

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Product 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.

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Together 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.

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Complying 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.

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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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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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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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