SMART quality & compliance
2014 PDA Europe Conference on “Outsourcing/Contract Manufacturing” in Berlin
On December 2-3 the Parenteral Drug Association (PDA) held a conference on “Outsourcing/Contract Manufacturing” in the heart of Berlin. Two team members represented KVALITO at the discussions about the focal question: “Is Outsourcing your weakest link?” Besides the KVALITO team members from Switzerland and Germany, many global actors from all parts of the value chain and its institutional environment participated. From major pharma companies, for instance, Pfizer, Baxter, Teva Pharmaceutical Industries, Boehringer Ingelheim, Bristol-Myers Squibb, F. Hoffmann-La Roche as well as many other innovative players from the industry took part. After a brilliant key note presentation by Fi Alonso-Caplen of…
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SMART quality & compliance
15th DIA Conference on European Electronic Document Management
Two of our consultants recently represented KVALITO at the 15th DIA Conference on European Electronic Document Management, held on December 2-3 in Berlin, Germany. A wide range of interested parties attended the conference, from big pharma (Pfizer, Sanofi, Bristol-Meyers Squibb, GSK, Bayer, Novartis, Roche), health authorities (FDA, BfArM, Egyptian Ministry of Health, MHRA), providers and vendors, to hear new information about electronic document management in the area of clinical trials and pharmacovigilance. Key topics that emerged from the conference presentations and discussions included: Upcoming EU Clinical Trial Regulation: Discussion and presentation about the upcoming clinical trial regulation and its impact…
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SMART quality & compliance
Digital Health Compliance
“I think the biggest innovation of the 21st century will be at the intersection of biology and technology. A new era is beginning” Steve Jobs On the Brink of Innovation You might not know it yet,but you are living in the digital era. You may have heard a friend talk about it, heard something on the news, or even downloaded an app. Whatever it is, digital healthcare is becoming the IT thing. More and more digital health applications are installed on smartphones, a number that is foreseen to grow exponentially. The United States alone is investing some 1.6 billion dollars…
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