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PUBLICATIONS

European Pharmaceutical Contractor

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Autumn 2018

   
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Legal & Regulatory
Risk-Averse Cultures in New Product Development

Accelerating Development

Brion Regan at ERT discusses the surge in technological developments across the pharmaceutical industry, highlighting that their adoption across the field is low.
 
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Applying Quality Best Practice Principles

Quality Compliance

Patricia Santos-Serrao at MasterControl breaks the traditional view that clinical and manufacturing in life sciences operate in separate spheres by exploring the similarities they share.
 
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Clinical Partnerships in the NHS

Clinical Service

Bernard Ross at Sky Medical Technology puts forward the notion that the pharmaceutical and biotechnology industries need to prioritise clinical partnerships through clinician-first approaches.
 
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Application of Good Clinical Practice Principles

Right First and Every Time

One historic challenge in clinical research has been maintaining the balance between safety and effectiveness. Dr Suzanne Pavon at TFS explores different management approaches to combat this.
 
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Published quarterly in
February, May,
August, and November

News and Press Releases

WuXi STA and Dizal Pharmaceutical Sign CMC Development and Manufacturing Agreement

STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – and Dizal Pharmaceutical, a biotechnology company, announce a strategic partnership. Under the terms of the collaboration, WuXi STA will become the preferred CDMO partner of Dizal Pharmaceutical for GMP production, providing integrated CMC (Chemical, manufacturing and Control) process research and manufacturing services from API to drug product.
More info >>

White Papers

Recommendations for Implementing Assessment Criteria Guidelines in Lymphoma and Chronic Lymphocytic Leukemia Clinical Trials

Perceptive Informatics

Standardized assessment criteria are becoming increasingly important in obtaining valid outcomes in oncology clinical trials. While standardized criteria encourage a more uniform approach to assessing clinical trial data, they are often subject to the interpretation of the user. These differences in interpretation, while seemingly minor, can have a major impact on assessments. The most commonly used standardized criteria for lymphoma have been no exception. Differences such as minimum new lesion size, lymph node normalization size requirements, inclusion of extranodal lesions and assessment of organomegaly can have a profound effect on overall response. Additionally, heightened scrutiny of the assessment criteria used in a given protocol can lead to questions about a drug’s efficacy if not applied correctly according to regulators’ interpretation.
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Industry Events

World Vaccine Congress Washington

27-29 September 2020, Walter E Washington Convention Center, Washington, US

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
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