Newsletter - 1116-02
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Issue #1116
 
 
Top Articles
 
 
1. End of Quality by Design
 
Understanding the history of Quality by Design is very important if we want the concept to become entrenched in the pharma industry. Here, we journey from the industrial revolution to the modern day, and ask: can we ever truly reach an “end” to QbD?
 
 
 
 
2. Bluff or Serious Biosimilar Bet?
 
The players and chips are ready, and cards are being closely guarded; but in order to get a clue on who is most likely to command this game, we must examine who is at the table, peek at their cards, and imagine how they might play…
 
 
 
 
3. The Great British Debate
 
On June 23, 2016, the United Kingdom voted to leave the European Union. Much of the debate centered on the general pros and cons, but we asked a more important question: What could “Brexit” mean for the pharma industry?
 
 
 
 
 
Ireland has many success stories when it comes to biopharma. Here, IDA’s Barry Heavey provides a short history lesson on Irish biopharma and looks at how the country has managed to compete with larger nations for investment. Read article
 
 
Leo Pharma’s Open Innovation platform grabbed the gold in The Medicine Maker’s inaugural Innovation Awards. Here, one of the masterminds behind the project explains how a single-minded focus changed hearts and minds. Read article
 
 
 
 
 
On Demand Webinars
 
 
Guideline on Elemental Impurities: Challenges and approaches for implementation
 
This webinar provides an overview of the ICH Q3D guideline on elemental impurities, its challenges and approaches for implementation. We discuss the impact of elemental impurities on drug product and pharmaceutical starting materials, and you will learn risk-based approaches to assess and implement control strategies and how this can be supported with dedicated documentation.