M7 - Working with Regulatory Agencies - Structure of the Regulatory Agencies for Medical Devices (QP)
PrintPart of Medical Devices QP Training Module 7
£735.00 exl VAT
About this course
A one day course aimed towards outlining the structure of regulatory agencies and the allied agencies involved in ensuring public health and safety is addressed within medical devices. This course focuses specifically upon the European regulatory agencies, expert groups and notified body coordination groups, providing you with essential intelligence as to how Europe really establishes regulatory oversight. If you are familiar with the medical devices, directives in Europe you will find this course absolutely essential to your future in medical devices as it demystifies how medical device legal, product safety and regulatory oversight is truly shaped and the bodies that come together to shape it.
Who Should Attend
The course is aimed at personnel within the organization involved specifically with scientific and/or regulatory affairs strategic planning and regulatory enforcement. In a world where regulatory scrutiny has increased several-fold it is crucial that professionals are capable of communicating effectively with their regulatory agency both at pre-clinical, pre-submission, submission and regulatory enforcement phases. The course also provides excellent guidance upon responding to regulatory agencies during times of business critical enforcement.
