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The MDR in Ireland: The Medical Devices Regulations 2021 Mason Hayes Curran

Optimising regulatory information management


Optimising regulatory information management
Pharma companies have been focused on integrating systems containing regulatory data, to automate data flows and enhance compliance. Now attention is shifting to how best to reveal interdependencies between data, documents and processes to drive efficiency and further automation. Romuald Braun, VP of Strategy for Life Sciences at Amplexor, offers some guidance to pharma businesses looking to optimise their regulatory information management (RIM) automation.
Keeping on top of regulatory requirements in life sciences is a full-time occupation, as the landscape is in a constant state of flux. The new demands each year are considerable, and 2021 will be no exception. It was already set to be a big year for new compliance deadlines, and now the continuing COVID-19 pandemic is driving new urgency around streamlining and accelerating processes and shoring up data quality. ....

United Kingdom , Romuald Braun , Eurasian Economic Union , Strategy For Life Sciences At Amplexor , Life Sciences , Devices Regulation , ஒன்றுபட்டது கிஂக்டம் , ரொமுல்த் மூளை , யூரேசியன் பொருளாதார தொழிற்சங்கம் , வாழ்க்கை அறிவியல் , சாதனங்கள் ஒழுங்குமுறை ,

As Europe Prepares for New Regulations, RAPS Euro Convergence Gathers Regulatory Pros Online for Updates, Discussion, and Debate, 10–12 May


As Europe Prepares for New Regulations, RAPS Euro Convergence Gathers Regulatory Pros Online for Updates, Discussion, and Debate, 10–12 May
April 22, 2021 13:56 ET
| Source:
Regulatory Affairs Professionals Society (RAPS)
Regulatory Affairs Professionals Society (RAPS)
Rockville, Maryland, UNITED STATES
Rockville, MD, USA, April 22, 2021 (GLOBE NEWSWIRE) The Regulatory Affairs Professionals Society (RAPS) will hold its annual RAPS Euro Convergence, a three-day conference devoted to European healthcare product regulations and regulatory issues,
10–12 May. This year’s program will feature more than 130 expert speakers and more than 40 educational sessions taking place all online. Attendees will hear from speakers representing the European Commission (EC), the European Medicines Agency (EMA), national health authorities, notified bodies, and the medical device and pharmaceutical industries. ....

United States , United Kingdom , Gert Bos , Sabina Hoekstra Van , Regulatory Affairs Professionals Society , Qserve Group , European Medicines Agency , European Commission , Devices Regulation , Vitro Diagnostic Regulation , ஒன்றுபட்டது மாநிலங்களில் , ஒன்றுபட்டது கிஂக்டம் , ஒழுங்குமுறை வாழ்க்கைத்தொழில்கள் ப்ரொஃபெஶநல்ஸ் சமூகம் , ஐரோப்பிய தரகு , சாதனங்கள் ஒழுங்குமுறை , விட்ரோ கண்டறியும் ஒழுங்குமுறை ,