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Regulatory Affairs

News Regulatory Affairs

  • Focus on Medical Device Regulation

    The EU Medical Device Regulation heralds a new era for the medical technology sector: in future, any company wishing to bring medical devices to market must face the requirements of this new regulatory framework. This implies a sizeable challenge for the many small and medium-sized enterprises in Ge more

  • PharmaLex Group acquires The Degge Group

    The PharmaLex Group, provider of development consulting and scientific affairs, regulatory affairs and pharmacovigilance, has completed the formal merger with The Degge Group, Ltd.  The company is based just outside Washington, DC, in Fairfax, Virginia, USA. The Degge Group’s focus on pharmacoepide more

  • uniQure Appoints Alexander Kuta as Senior Vice President of Regulatory Affairs

    uniQure N.V. announced the appointment of Alexander Kuta, Ph.D., as Senior Vice President of Regulatory Affairs. Dr. Kuta has more than 25 years of regulatory experience within the industry, having previously held leadership positions at Genzyme Corporation, EMD Serono, AMAG Pharmaceuticals and Lant more

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Events Regulatory Affairs

Course
26-09 – 27-09
2018
Washington D.C., US

How FDA Trains Its Investigators and Inspectors to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection

Course "How FDA Trains Its Investigators and Inspectors to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Senior m

Course
18-10 – 19-10
2018
Washington D.C., US

Complaint and Recall Management: A Compliant, Lean Program

Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportabl

Course
11-11 – 12-11
2018
Burlingame, US

FDA Scrutiny of Promotion and Advertising Practices

Overview: Course "FDA Scrutiny of Promotion and Advertising Practices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of

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Market studies Regulatory Affairs

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Definition

Office of Regulatory Affairs

Office of Regulatory Affairs The Office of Regulatory Affairs (ORA) is the part of the United States FDA that enforces the laws that govern food, drugs, medical devices, and other products that FDA regulates. Organization It is organised ... more

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