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PharmTech Europe
13 February 2018

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Top Stories

Pharmapack Award Winners of 2018 Revealed

The Awards honor innovations in drug delivery and packaging, for better patient safety and compliance.
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Annex 1 Misses the Mark

Viewpoint: The revised Annex 1 on sterile manufacturing includes incorrect and ambiguous statements that must be fixed before implementation.
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Industry News

EMA Management Board Meets to Discuss New Location

The agency met to discuss its new temporary and permanent premises in Amsterdam.
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CPhI Names "Medical Futurist" as First CPhI North America 2018 Keynote Speaker

CPhI North America 2018, taking place Apr. 24-26 in Philadelphia, PA, has announced Dr. Bertalan Mesko as its first keynote speaker.
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Regulatory News

Barriers to ATMP Drug Development

Greater clarity and harmonization in ATMP regulations are needed to promote the development and commercialization of these therapies.
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Roadmap Aims to Replace Animal Use in Toxicity Testing

Federal agencies have partnered to develop a roadmap that offers a new framework for the safety testing of drugs and chemicals without the use of animals.
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Bio/Pharma News

Amgen to Invest $300 Million in New Biomanufacturing Facility

Amgen plans to invest approximately $300 million in a new biomanufacturing plant in the United States.
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Paratek Submits NDAs for New Antibiotic

Paratek has completed submission of two new drug applications for oral and intravenous omadacycline, a new antibiotic for pneumonia and skin infections.
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Supplier News

Avista Pharma Acquires Solid Form Solutions

Avista Pharma’s strengthens early phase drug development offerings with acquisition of Solid Form Solutions.
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Cambrex Expands API Development at Iowa Facility

Cambrex invests in development and laboratory facilities and adds staff.
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FEATURED TOPICS

ANALYTICS

Analyzing Content Uniformity

New technologies, such as NIR and Raman, enable online measurements of blending and content uniformity in the production of solid dosage forms.
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BIOLOGICS

Impurity Testing

Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
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Manufacturing

Material Traceability in Continuous Pharmaceutical Tablet Manufacturing

A systematic framework and software are needed to implement material traceability in continuous pharmaceutical tablet manufacturing.
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EXCIPIENTS

Managing Risk in a Complex Excipient Supply Chain

Regulations and industry guidelines focus on ensuring excipient safety by specifying risk assessments and shared responsibility.
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Product Profiles

Shimadzu

Metal-free Prominence Inert LC System
Shimadzu's Prominence Inert LC system, a metal-free instrument, is ideal for analyzing aggregates or other biological macromolecules in biopharmaceuticals.
/ Read more/

Starna Scientific

Ensure your Instrument Performance Qualification (IPV) is fully compliant!
Starna announce accreditation to the new Reference Material Producer (RMP) ISO 17034 Accreditation for its Certified Reference Materials (CRMs) for Photometry IPV.
/ Read more/


Event Profile

BIO-Europe Spring® 2018 — 12th International Partnering Conference

Date: 12 – 14 March 2018
Venue: RAI Amsterdam, Amsterdam, The Netherlands

Where the global biotech industry comes to partner
BIO-Europe Spring® is the springtime counterpart to EBD Group's flagship conference, BIO-Europe®, and continues the tradition of providing life science companies with high caliber partnering opportunities.
/ Read more/


LIVE WEBCASTS

Assessing Product Integrity Risk Profiles and Engineering On-Dose Authentication During Drug Development Process
Live Webcast: Thursday, February 15, at 1:00pm EST
Register now


Top Quality Trends for 2018 Pharma Quality Survey Report
Live Webcast: Wednesday, March 7 at 11:00am EST
Register now


Events

IFPAC-2018

North Bethesda, Maryland, US

11–14 February 2018

9th Global Drug Delivery & Formulation Summit

Berlin, Germany

12–14 March 2018

Paperless Lab Academy 2018

Milano, Italy

20–21 March 2018


more events

eBOOKS

Vaccines Development and Manufacturing 2017

Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.

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