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PharmTech Europe
24 January 2017

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Top Stories

Switching Studies Crucial to Demonstrate Biosimilar Interchangeability

FDA released a long-awaited draft guidance to help sponsors seeking to demonstrate interchangeability for biosimilar products.
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Elasticity–A Modern Paradigm for a High Performance Workforce

Top C-suite leaders are already tuning their long-range planning, hiring practices, and business systems for elasticity. Are you ready?
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PODCAST

Keith Hutchison, senior vice president of Research and Development, Capsugel, speaks with Pharmaceutical Technology Europe about the applications of this technology in formulation development.

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Industry News

Data Integrity Problems Found at Japan Facility

FDA cites Sato Yakuhin Kogyo Co., Ltd. with data integrity violations after a June 2016 inspection of its Kashihara City facility.
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Europe Updates Elemental Impurities Strategy

EDQM outlines the steps it will take to implement the ICH Q3D guideline on elemental impurities.
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Regulatory News

ICH Publishes Presentation on Q3C Revision

The presentation details the addition of triethylamine to the guideline on toxic solvents.
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EMA Releases 2016 Highlights

The agency published an overview of marketing authorizations made in 2016.
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More Regulatory News

Bio/Pharma News

Biogen Pays $1.25 Billion to Settle Tecfidera Patent Dispute

The company agreed to pay Forward Pharma $1.25 billion to settle a patent dispute over the formulation of Tecfidera, the company's leading multiple sclerosis treatment.
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GSK Makes Staff Changes to Global Pharmaceuticals Division

Luke Miels will replace Abbas Hussain as president of GSK's Global Pharmaceutical division later this year.
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More Bio/Pharma News

Supplier News

MilliporeSigma Opens Production Facility in Mollet des Vallès

The company opened a facility in Spain dedicated to the production of meglumine.
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Bischof + Klein Invests in New Coex Extrusion Line

With this new line, Bischof + Klein will double its extrusion capacities for its CleanFlex clean room films.
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FEATURED TOPICS

GLOBAL REPORT

Bio/Pharma's 2017 Agenda

Healthcare policies, R&D investments, and drug approvals will test bio/pharma.
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PEER-REVIEWED RESEARCH

A Statistical Decision System for Out-of-Trend Evaluation

The authors present a set of statistical decision rules based on linear regression models that can be implemented in an automated trend system to assist stability studies.
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QUALITY

The Transition to Electronic Records

A four-stage process to successfully make the switch from paper to electronic batch records is presented.
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MANUFACTURING

Point-of-Use Leak Testing of Single-Use Bag Assemblies

The authors describe the development and validation of a highly sensitive point-of-use pressure decay test.
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Product/Service Profile

SCHOTT AG, Germany

perfeXion™
SCHOTT is integrating a specially developed big data solution into its pharmaceutical tubing production, replacing statistical sample-based quality assurance with 100 percent on-line measurement.
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Events

Pharmapack Europe

1–2 February, 2017

Sartorius Research Xchange Forum 2017

22–23 February, 2017

CPhI Istanbul

8–10 March, 2017


more events

Reference Library

Pharmaceutical Technology Solid Dosage Combo

Increase your knowledge of solid dosage technology and solid dose tablet manufacturing processes. These comprehensive pharmacology reference guides cover a variety of solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Drug delivery system manufacturing professionals can use the solid dosage manufacturing books to stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development.
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More Reference BookS

eBOOKS

Bioprocessing & Sterile Manufacturing eBook

Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems.

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