Course description
Regulatory Information Management & IDMP Training (GPRAS)
Regulatory Information Management (RIM) software is vital in an industry where vast amounts of regulatory information must be gathered from multiple departments, then submitted to the regulatory agency for approval. When an organisation has many products RIM becomes even more crucial to regulatory operations and requires strategic planning. Identification of Medicinal Products (IDMP) was designed in response to demand for harmonised specifications for medicinal products. Currently the identification of medicinal products is dependent on the country and company but changes to this under the new IDMP standards are imminent.
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Suitability - Who should attend?
This course is relevant for anyone working with RIM or IDMP either directly or indirectly and may include people working in the following areas:
- Regulatory Affairs
- Dossier & Document Management
- Data Management
- Electronic Submissions
Outcome / Qualification etc.
You will learn the key aspects of RIM and the newIDMPstandards such as training and user compliance, outsourcing and data/content management. Once completed you will have the necessary skills to plan, prepare and implement a strategy ready to meetIDMPdeadlines and help you get to grips with the key aspects of electronic submissions.
Training Course Content
- Gain a complete overview of RIM and appreciate what systems are available on the market
- Learn how to successfully manage content by discovering tools to pull metadata
- Examine the importance of RIM systems linking key departments
- Fully understand the new ISO IDMP standard and how it impacts your organisation
- Learn how to apply a step by step strategic approach to prepare for IDMP
- Evaluating best practices for standardising and preparing data ready for IDMP
- As an SME you will gain useful tips and advice when approaching RIM and IDMP
- Discover how to outsource RIM and IDMP
- Examine how best to roll out training to ensure user compliance within large organisations with both RIM and IDMP
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5