ESPL Regulatory Consulting

Training

ESPL provides in-house regulatory training programmes and is actively involved in supporting TOPRA with its MSc programme for Medical Devices, and in QP training.  In 2012 the principal trainer, Helen Erwood, was nominated for the TOPRA “Inspiration” award.

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.

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