What can we say; we love teaching and imparting knowledge and experience to help others succeed in their careers, and we offer training that is interactive and memorable.
- 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
“I love teaching because it keeps me on my toes! Finding imaginative ways to put regulatory concepts across is something I feel really passionate about. What really makes my day is when someone new to a concept comes for training and leaves happy and really understanding it.” Helen Erwood, Chairman
We offer tailored training courses which can also include
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 bespoke training, we would agree with the client what aspects of the subject matter need to be covered and design a programme that includes face-to-face or online presentations together with interactive exercises to enhance learning.
For more information on our training services please get in touch via the form below to arrange a consultation.
We provide flexible and comprehensive support for clinical trial, MAA and NDA submissions for both small molecule and biological products. We can prepare all relevant documents, review your documents, and publish submissions. We can also act as an MA Holder in the UK and EU.
ESPL has significant experience in supporting clients with local and global regulatory strategies, as well as preparing and coordinating advice from regulatory agencies for a wide range of different therapeutic areas with both SME’s and big Pharma. We also support clients with PRIME, PIP, Orphan, ATMP and drug-device applications.
Our own in-house publishing team can publish and maintain your e-CTD for EU and US submission, including ASMFs/DMFs and CEPs. The team can publish your documents, and submit them via CESP, MHRA Portal, FDA ESG, etc.
At ESPL we offer a comprehensive regulatory affairs training package. In 2012 the principal trainer, Helen Erwood, was nominated for the TORPA “inspiration” award, and several team members lead and present at TOPRA training courses.
Regulatory activities don’t just stop when the MAA/NDA is granted, which is why ESPL provides support for the full life cycle of your product. We can provide services to maintain/vary your licences, to manage Sunset Clause submissions, and to extend your regulatory licences into new markets.