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White Papers

Pharma is devoted to providing pharma professionals with the most comprehensive selection of case studies and white papers on the internet. Get in-depth information through Pharma IQ's pharma and biotechnology white papers. Our white papers aim to educate industry leaders as they make complex business decisions that drive growth, innovation and ROI. 

354 whitepaper results
of 35
Serialisation, Serialization, CMOS, contract manufacturing organisation, small and medium enterprise, pharma, biotech, pharmaceutical

Pharma IQ spoke to Mark Davison, Chief Executive Officer Blue Sphere Health Ltd to gain insight on his experience working with SME pharma & biotechs for serialisation. Also we spoke to Vetter pharma – a responsible CMO for their insight on how peer CMOs can scale the summit that is serialisation.Learn more

Early Access Programmes, Market Access, Compassionate use, Managed Access Programme, pharma, orphan drugs, special access scheme, biologics, biotechs

Ahead of this year’s Early Access Programmes Europe conference, Pharma IQ expands its regulatory handbook to develop the industry’s awareness of the various compliance requirements that surround the implementation of these programmesLearn more

cover

Industry stakeholders have insisted that it could be a costly mistake to view serialisation as a project which only concerns engineering matters. As serialisation data is unique to the pack it requires not only the deployment of new treatment but also expanded staff investment and stakeholder engagement. Therefore, “To characterize it as an engineering issue is therefore to grossly underestimate its consequences, which touch virtually every business function in pharmaceutical manufacturing.”Learn more

Inspection

If you were handed with a notice for a clinical trial inspection plan right now, how would you react? - With a feeling of asserted confidence or a rush of slight concern? Wherever you think you would stand on this spectrum, use this infographic to learn from your peers’ mistakes. Pharma IQ invites the expertise of Andy Fisher Senior GCP Inspector MHRA on a list of common TMF failings.Learn more

seri

As the serialisation industry prepares for various approaching deadlines all over the globe, Pharma IQ has created a printable map to assist with your worldwide track and trace compliance strategies.Learn more

etmf

The transition from paper to electronic Trial Master File (TMF) system, is a significant task, which is further complicated with the varying views and opinions complicating the route to standardisation. This is partially solved by the new directives under construction alongside the EMA’s updated information providing giving insight into inspector’s reviewing behaviours and what has been examined as of late for eTMFs. These much needed points of clarification help inform pharma and biotech companies on how to best create and maintain an eTMF system.Learn more

trans

By having visibility on how far away the reality of an airtight Trial Master File is, a pharma firm has an opportunity to alter the project’s trajectory if needed. This transparency can be obtained via a range of avenues which include: solid metrics, clear oversight, frequent exchanges with the CRO and accurate understanding of the required documents.Learn more

Bio talking heads

Ahead of the 2016 Lab Informatics Summit, Pharma IQ discussed the subject of data knowledge management with lab informatics and more specifically manufacturing with a selection of experts.Learn more

Bio oc2

With the growth of biologics showing no signs of stopping, bioinformatics continues to be a key driver when it comes to R&D development. Ahead of this year's Lab Informatics Summit, Pharma IQ speaks to an array of experts on the subject of data knowledge management with complex datasets.Learn more

lab info

Ahead of the Lab Informatics Summit, Pharma IQ presents a selection of considerations to assist labs on their route to full integration and interoperability.Learn more

354 whitepaper results
of 35