The companies announced that they have mutually decided to terminate the planned merger after the US Department of Treasury and the IRS issue temporary and proposed regulations on tax inversion. / read more /
The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug. / read more /
Even though the organizers of New York’s Tribeca Film Festival decided not to air the anti-vaccine film by discredited British researcher Andrew Wakefield, the so-called documentary is getting a healthy run and further perpetuating the myth of a link between childhood vaccination and autism. / read more /
Ensuring Effective Drug Stability Studies Drug Stability Testing from Development to Shipping
LIVE WEBCAST: US: Wednesday, April 20, 2016 at 11 am EDT and EU: Wednesday, April 27, 2016 at 11 am CEST In this educational webcast, learn about regulatory expectations and practical approaches to stability testing of drug substances and drug products for clinical trials, packaging, storage, and transportation.
Free registration
Sandoz Industrial Products GmbH will be renamed Corden BioChem and will be associated with the CordenPharma Group, ICIG’s pharmaceutical platform. / read more /
Employing a Lean Lab Approach to Optimize Lab Processes:
Part 1: Work Smarter Not Harder
LIVE WEBCAST: Tuesday April 26, 2016 at 7 am PDT | 10 am EDT | 2 pm GMT | 3 pm BST | 4 pm CET When lab workloads seem too high to handle, analysis results or approvals are late, or lead times are exceeded, it is time to take a closer look at a lean lab approach, especially before investing in new resources such as equipment, premises, or personnel.
Free registration
For successful partnerships, it’s important to take a long-term view, focus on simple designs, and address potential payer concerns up front. / read more /
This article focuses on the growing need for effective data management in the life sciences industry—especially among smaller pharmaceutical manufacturers. / read more /
Beat the Regulator: Proactive Risk Management in the Life Sciences
Staying on top of regulatory compliance can be a real struggle. While you comb your data and processes for regulatory compliance issues, are your competitors stealing a march on you?
/ Read more /
Expanding solutions for elemental impurity analysis in pharmaceutical products
Shimadzu has released its new ICPMS-2030 Inductively Coupled Plasma Mass Spectrometer. It meets the requirements of the ICH Q3D guidelines for elemental impurities in pharmaceutical products. / Read more /
KEYNOTE SERIES AT INTERPHEX 2016
At INTERPHEX 2016, Pharmaceutical Technology and BioPharm International are sponsoring a Keynote Series addressing leading bio/pharma industry issues.
In a panel discussion, Industry experts will discuss how technology advances are addressing challenges in biopharmaceutical development including quality control of raw materials, implementation of single-use technologies, process monitoring, and downstream purification.
Tuesday, April 26, 10:15 am to 11:45 am Learn more
How will consolidation in the bio/pharmaceutical and contract services market, a changing financial market, and an active political and regulatory year shape the fortunes of the contract services market? In his annual presentation, industry expert Jim Miller will offer his perspectives on the contract services landscape for the next few years.
Wednesday, April 27, 10:30 am – 11:30 am Learn more
Sterile injectables have been in extremely short supply, and industry efforts have been focusing on root causes involving infrastructure, quality, and efficiency. Experts involved in this work discuss recent initiatives, and offer insights into what must be done to prevent injectables shortages in the future.
Wednesday, April 27, 3:30 – 4:30 pm Learn more
In this 60-minute webcast, experts will explain the concept of water activity and its relationship to the growth of microorganisms. Key regulatory guidance and compendial documents will be reviewed. Sponsored by Aqua Lab by Decagon
On Demand
Considerations for preparing for the process transfer, ensuring equipment and materials consistency, and post-transfer activities will be discussed. Sponsored by Rottendorf Pharma
Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations. / Click here /
New materials, instruments, and processes are facilitating solid-dosage drug formulation and manufacturing. This ebook reviews methods to address quality issues for APIs, excipients, and intermediates; analysis methods for elemental impurities and continuous powder processing; modeling tools to improve workflows, and methods to improve tablet compression.
