At ESPL we firmly believe that keeping people informed about regulatory requirements is the key to success.
We therefore provide:
- In-house regulatory affairs training to support teams at all levels
- 1:1 senior management mentoring – for managers and directors new to regulatory affairs
- Specific subject webinars for “virtual” teams, in a wide variety of regulatory subjects
We also support TOPRA by providing lectures for their training modules, such as Market Access and the MSc course in Medical Devices.
Our courses cover a wide range of topics appropriate for the EEA and North America, for example:
- Regulatory submission procedures for medicinal products and medical devices
- PIP, PRIME and Orphan procedures
- Life Cycle management of medicinal products and / or medical devices
- Data requirements for Modules 2-5 in the EEA / USA
- Development of ISO 13485 Quality Management Systems
- ISO 14971 Risk Management for Medical Devices
Life cycle management of medicinal products and medical devices, including:
- Variations procedures / Changes to an NDA / sNDA
- Regulatory Compliance for QA functions
- Acquisitions, divestments and sunset clause requirements
In addition, we provide courses designed to optimise other regulatory professional skills, such as:
- Negotiating with regulatory agencies
- good writing practices and preparing files for publishing.
For more information on how ESPL can support your business, contact us via the form below, and we can arrange a consultation.