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The Trend in Biosimilar Development and Recent FDA Guidance

Statistical Consultancy Team

At the present time, the regulatory and drug development communities are adapting to a rising trend in biosimilar development in a number of therapeutic areas.

The regulatory framework for biosimilars in the US is still evolving; the number of biosimilars approved by the FDA in 2015 was 1, this rose to 4 in 2016 and is set to increase in 2017. The FDA is developing and consulting on draft guidance documents that will shape future trials, and at this early stage there are a number of legal issues to be agreed around licencing conditions, such as the period of exclusivity and the applicability of the biosimilar to all approved indications of the reference product. To put this in context with the European landscape, biosimilars have been approved and used in the EU for over a decade without highlighting any major safety concerns. As of April 2017, there were 28 approved biosimilars in the EU on 11 different biologics. However, there are aspects of the emerging FDA guidance that will almost certainly be reflected in the evolution of trial designs in the future, for products aimed at the US market.

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Topics: Regulatory Requirements, Pharmacokinetics and Pharmacodynamic, FDA, Clinical Study Design, European Medicines Agency, Bioequivalence, PK Analysis, Demonstrating Biosimilarity, Biosimilars

The History of Pharmacovigilance Infographic

Pharmacovigilance Team
Where and when did Pharmacovigilance begin? Medical remedies have been recognized by mankind for thousands of years, and so have their potential dangers, side effects, and benefits. During the 20th century there were some serious adverse events associated with medical products and drugs that resulted in pressure on governments, businesses to produce legalization and guidance, as well as the evolution of regulatory bodies to protect the safety of patients. This infographic identifies those significant milestones across the 20th century and into the modern era.
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Topics: FDA, Adverse Events (AEs), Pharmacovigilance, New Pharmacovigilance Legislation, Good Pharmacovigilance Practices, European Medicines Agency, Patient Narratives, Black Triangle

mHealth Apps and Wearables in Clinical Trials to Consider

Nick Burch

Today, mHealth, Mobile Health, Mobile Apps and Wearables are hot topics with consumers and regulators alike. We're also starting to see consumer-grade wearables and mHealth technologies creeping into clinical trials. We've written this blog for those looking to use this area more.

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Topics: Regulatory Requirements, FDA, European Medicines Agency, Quality Assurance, Mobile Device, Technology Trends, Wearables in Clinical Trials, Wearables, mHealth

Ben Goldacre Discusses Clinical Data Transparency [Video]

Statistical Consultancy Team

Dr Ben Goldacre, author of 'Bad Pharma' presented a keynote speech at the Clinical Data Live! symposium on clinical data transparency. 

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Topics: Regulatory Requirements, Good Clinical Practice (GCP), FDA, Electronic Medical Record (EMR), Adverse Events (AEs), Historical Data, European Medicines Agency, Clinical Trial Documentation, Clinical Documents, Ethics, Accessible Data, Data Transparency

Data Transparency in Clinical Trials Q&A with Ben Goldacre [Video]

Statistical Consultancy Team

Q&A on Data Transparency in clinical trials with Dr Ben Goldacre, Katherine Hutchinson & Kevin Carroll at Clinical Data Live!

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Topics: Regulatory Requirements, Good Clinical Practice (GCP), FDA, Adverse Events (AEs), Historical Data, European Medicines Agency, Ethics, Phase 3 Studies, Accessible Data, Phase 4 Studies, Data Transparency

Pharmacovigilance - The Black Triangle and Additional Monitoring

Pharmacovigilance Team

 

In July 2012 the new Pharmacovigilance legislation came into effect with a focus on robust systems for public health that encourage efficiency and transparency. The EMA Executive Director Guido Rasi explained that:

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Topics: Pharmacovigilance, New Pharmacovigilance Legislation, European Medicines Agency, Additional Monitoring, Black Triangle

Are you ready for the New Pharmacovigilance Legislation?

Pharmacovigilance Team

As the European Medicines Agency finalizes the first set of Good Pharmacovigilance Practices are you ready for the Transition to the New PV Legislation?

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Topics: Pharmacovigilance, New Pharmacovigilance Legislation, Good Pharmacovigilance Practices, European Medicines Agency

Compliant with the new Eudravigilance Medicinal Product Dictionary?

Pharmacovigilance Team

With just over a week to go before the Article 57(2) requirements for population of the eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD) become mandatory, the European Medicines Agency (EMA) has today published an updated version of the ‘eXtended EudraVigilance Medicinal Product Report Message (XEVPRM) Frequently Asked Questions & Answers (FAQs)’ document.

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Topics: Pharmacovigilance, Eudravigilance, Medicinal Product Dictionary (XEVMPD), New Pharmacovigilance Legislation, Good Pharmacovigilance Practices, European Medicines Agency

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