Together Beyond COVID-19 - A Look to the Future

International Pharmaceutical Industry: Marta Vila Ramos discusses the impact of COVID-19 on the industry and what we can expect in the future.

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The Outlook for a Year of Change

Over the past 12 months, the bio/pharma industry has faced unprecedented challenges head on, working in unique and remote ways, and forming new and unlikely partnerships to help in the fight against the COVID-19 pandemic. Although a hugely impactful aspect of 2020, COVID-19 has not been the only trial of the year; bio/pharma companies have also had to keep a watchful eye on Brexit—the departure of the United Kingdom from the European Union—which is expected to cause broad-level disruptions to companies throughout the region.

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Teknoscience publication: Successful marketing of medicinal cannabis

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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Successful marketing of medicinal cannabis 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 part I

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

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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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IPI publication: Successful marketing of medicinal cannabis

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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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 NPD 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 - the regulatory intelligence the platform deserves

PharmaLex’s Jürgen Hönig and Rob Williams discuss the key elements of developing a successful knowledge-management plan – p12

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Latin America Leans 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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In the case of a ‘no deal’ Brexit: the supply of medicines

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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AI in drug development: Regulatory Affairs - 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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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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