A statement from the Bionical Emas Group on guidance & measures regarding COVID-19 - read here

In relation to staff and visitor safety, we have full risk assessments in place for all of our workplaces. These risk assessments are revisited and updated regularly, to reflect changing risks, knowledge and circumstances, and to reflect evolving Government guidance. We have not placed the risk assessments here on the website as they would become out of date too quickly. However, you are welcome to email info@bionical-emas.com to request access to our most up to date risk assessments applicable to your needs. Please note that all our staff are notified of all applicable risk assessments and updates, along with ‘quick guides’ automatically via our e-learning system.

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Explore our resource section below. If you have any questions about information or resources you can’t see here, get in touch. We endeavour to respond to your enquiry within 24 hours.

Fact Sheet
Early Access Programs (EAP)

Four things to think about: PVG in EAPs

By Nisha Vora - Senior Project Manager, Pharmacovigilance

Fact Sheet
Early Access Programs (EAP)

Nuances in Pharmacovigilance case processing in Early Access Programs

By Harry Woods - Pharmacovigilance Associate

Press
Early Access Programs (EAP)

What does Early Access actually mean?

Naomi Litchfield, Patient Advocacy Manager for Bionical Emas, discusses the basic principles of Early Access Programs

Fact Sheet
Clinical Development

Pharmacovigilance & CIOMS

By Negin Goudarz - Senior PV Associate

Press

How have Bionical Emas adapted as a business during COVID-19?

An interview with Kathleen DeHaven, Director of Clinical Operations North America

Press Release Early Access Programs (EAP)

Bionical Emas and Jazz Pharmaceuticals Enter into an Agreement for Expanded Access to Lurbinectedin in Relapsed Small Cell Lung Cancer in the United States

Press

Women In Healthcare – PharmaTimes May 2020

Press
Early Access Programs (EAP)

The Early Access Voyage – Rare Revolution Spring 2020

Case Study Clinical Development

From kick-off meeting to SIV in five days – a severe COVID-19 pneumonia case-study

Press Release Early Access Programs (EAP)

PharmaMar and Bionical Emas launch Expanded Access Program for lurbinectedin in relapsed Small Cell Lung Cancer in the U.S.

Case Study Clinical Development

Effective Pharmacovigilance & Regulatory EU and Australian Due Diligence, leading to operational and consultative support

Case Study Clinical Development

Bionical Emas Regulatory Affairs: Mutual Recognition Submission Strategy

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