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 the 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.
You will learn the key aspects of RIM and the new IDMP standards 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 meet IDMP deadlines. With a dedicated day to each topic and practical elements on both days, this course will help you get to grips with the key aspects of electronic submissions.
Live Online Academies
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses.
Students will learn through:
- Live interactive sessions
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Revisiting recorded sessions with unlimited access for 30 days
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact firstname.lastname@example.org.
What will you learn?
Regulatory Information Management (RIM)
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
How to approach IDMP within a large organisation
Examine how best to roll out training to ensure user compliance within large organisations with both RIM and IDMP
How to approach IDMP as an SME
As an SME you will gain useful tips and advice when approaching RIM and IDMP
Discover how to outsource RIM and IDMP
Who is this course for?
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
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age, or educational level. This course has been assessed and is CPD certified.
Delegates of our live online academies said...
would attend another live online academy
found the course beneficial to their day to day role
would recommend the course to others