View 4 things to think about – PIPs and Waivers

4 things to think about – PIPs and Waivers

As part of Emas’ ‘4 things to think about’ series, we outline how Emas can help clients with the writing and filing of PIP applications within the EU. Paediatric development is a crucial part of all product development plans, with both US and EU Agencies focused on encouraging paediatric studies in parallel to development in…

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View EU orphan drug applications

EU orphan drug applications

1. Introduction To qualify as an orphan drug, a medicinal product must meet certain criteria as laid down in EU Regulation (EC) 141/2000 (Orphan Drug Regulation). Principally, a product will qualify as an orphan drug where the sponsor (= applicant) can show that: The Condition: The medicinal product is intended for the diagnosis, prevention or…

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View 4 things to think about – PRIME Applications

4 things to think about – PRIME Applications

As part of Emas’ ‘4 things to think about’ series, we outline how Emas can help clients speed up the development process for promising new medicines for patients whose diseases cannot be treated, or who need better treatment options. The European Medicines Agency (EMA) recently launched the PRIME (PRIority Medicines) scheme which is focused on medicines…

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View 4 things to think about for promotional copy review

4 things to think about for promotional copy review

As part of the Emas Pharma series ‘4 things to think about’, Rebecca Applin outlines key areas that those involved in the medical review and approval of promotional materials should consider. 1. Early medical input Early medical input can really help to promote efficiency in the review cycle of materials. In particular large or complex items or activities…

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View 4 things to think about for data management

4 things to think about for data management

As part of the Emas Pharma series ‘4 things to think about’, Senior Data Manager Tracie Lavery outlines key areas that data managers working with or within a CRO environment should consider. 1. It is all about the data The most important thing about a clinical trial is the data. As a data manager it is our responsibility…

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View 4 things to think about for medical case review

4 things to think about for medical case review

As part of the Emas series ‘4 things t o think about’, Medical Officer Raman Garcha outlines four areas that the medical team undertaking medical case review, within a CRO environment, should consider. 1. Preparation In terms of drug safety, know what the client wants and needs! This involves building a comprehensive understanding of the company, the product…

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View Adapting to process change

Adapting to process change

We provide case processing support to a global pharmaceutical company. In 2015, our client moved their global safety database to a new system. Our team adapted quickly to the new system, to deliver high quality, efficient case processing throughout the initial transition period and beyond. Challenges Creating effective, clear new case processing conventions. A short timeframe to adapt…

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View Ensuring compliance with rapid, accurate reporting

Ensuring compliance with rapid, accurate reporting

We are responsible for the submission of EU regulatory case reports for a global clinical trial, with a co-running trial using the same Investigational Medicinal Product (IMP), managed by another sponsor. In 2015, we received an extremely late case report from our client’s Pharmacovigilance (PV) team. Prior to this compliance and reporting had worked well….

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