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Collaborate to Innovate | Official blog of DIA Publications | Page 2

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Official blog of DIA Publications. Newer posts →. DIA’s Global Forum: Driving Ideas to Action. April 14, 2015. The April issue of DIA’s. Online magazine is now available at http:/ globalforum-online.org. In this issue, experts take a deep dive look into several of the trends to watch from DIA’s What Lies Ahead. Report which was released in February. The April issue is the first in our new reader-friendly and content-rich format, featuring fresh perspectives from industry experts. Continue reading →.

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DIA’s Global Forum: Driving Ideas to Action | Collaborate to Innovate

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Official blog of DIA Publications. What Lies Ahead 2015: Trends to Watch. In Case You Missed It: April Global Forum Looks at Industry Trends Across the Globe →. DIA’s Global Forum: Driving Ideas to Action. April 14, 2015. The April issue of DIA’s. Online magazine is now available at http:/ globalforum-online.org. In this issue, experts take a deep dive look into several of the trends to watch from DIA’s What Lies Ahead. Edith Frénoy, of EFPIA, examines the trend from a European perspective in The Rising ...

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What Lies Ahead 2015: Trends to Watch | Collaborate to Innovate

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Official blog of DIA Publications. Join Us in Paris for DIA’s Flagship European Offerings. DIA’s Global Forum: Driving Ideas to Action →. What Lies Ahead 2015: Trends to Watch. April 8, 2015. Have you seen DIA’s What Lies Ahead 2015 report yet? The third annual report was released earlier this year, providing experts’ insights into the year ahead for pharmaceuticals, biotechnology and medical devices. To read the full report, click here. In the upcoming April issue of DIA’s. Let us know in the comments.

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Widler and Schiemann AG can provide you with innovative, creative and cost effective answers to your questions and needs in the areas of Clinical Quality Management. With our vast experience and extensive network in the industry and the regulators we are uniquely positioned to identify and provide the best solutions for you. EU collaboration strengthens safety monitoring of medicines. European Commission publishes three-year report on implementation of pharmacovigilance legislation. EMA plans to revise g...

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The FDA’s Quality Revolution | Collaborate to Innovate

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Official blog of DIA Publications. The FDA’s Quality Revolution. July 14, 2015. By Peter J. Pitts. Let it be said that the spark that ignited the flame was when FDA leadership asked, Do we know enough about the quality of drugs that are sold in the United States. So said, CDER Director Dr. Janet Woodcock during yesterday’s webinar,. Understanding CDER’s Super Office Of Pharmaceutical Quality and Its Effect on You. Janet is the acting director of the OPQ and Lawrence is the acting deputy.). Since there is...

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The Globetrotting Regulator | Collaborate to Innovate

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Official blog of DIA Publications. Message from DIA 2015 51st Annual Meeting Program Co-Chair Dr. Michael Rosenblatt. The FDA’s Quality Revolution →. May 27, 2015. By Peter J. Pitts. I am putting in a lot of miles on behalf of international regulatory fraternity. At the top of the list is quality. In April I spent three fascinating days in Sharm El Sheikh, Egypt at the Second Arab Conference on Food and Drugs. It was all business and I didn’t even mind not getting any time to enjoy the Red Sea beaches.

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In Case You Missed It: April Global Forum Looks at Industry Trends Across the Globe | Collaborate to Innovate

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Official blog of DIA Publications. DIA’s Global Forum: Driving Ideas to Action. Disruptive Innovation in Health Care →. In Case You Missed It: April Global Forum Looks at Industry Trends Across the Globe. April 27, 2015. Have you read the April issue of. Featuring a new look, and in-depth content from an expanded editorial board, this issue is available open access (no log in required) at www.globalforum-online.org. Dr Ling Su and Fuyu Song offered their take on What Lies Ahead in China. How do you see t...

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THE FUTURE OF Post-approval Change Management - VRS | Virtual Regulatory Solutions

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THE FUTURE OF Post-approval Change Management. THE FUTURE OF Post-approval Change Management. Reproduced with permission from DIA North America. You can see the original here. By Sarah DeMare, Virtual Regulatory Solutions. Quality by Design (QbD). Christine Moore, Acting Director of Office of Process and Facilities at FDA, speaking recently at the 2075 DIA CMC Workshop, indicated that although QbD concepts are commonly used, the main focus has been on process understanding, rather than control strategy.