Ensure speedy regulatory approval and guarantee your filing variation procedures are cost-effective
Course Overview
Managing regulatory change for filing variations is a complex and challenging procedure. The regulatory requirements highlight the need for successful variations strategies across regulatory teams. It is therefore important for you to understand the regulations, definitions, and best practice for implementation.
This course will teach you how to optimise your procedures for faster, streamlined and compliant variation submissions. The course contains exercises and case studies to help you understand the variation requirements and meet your regulatory goals. You will examine the various types of variations from mutual recognition to type II and centralised procedure variations. You will also discuss how best to approach grouping and worksharing so you know when to apply it to your variations.
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, delivered in bitesize sessions of 1.5-3 hours online.
Over 2 weeks students will learn through:
- Live interactive bitesize 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 lifesciences-training@informa.com.
What will you learn?
Formulating variations
Formulating variations
Formulate variations procedures that achieve faster approval
Variation submission
Variation submission
Manage the practical hurdles of submitting your Variations on time and with the right supporting data
Impact of the CTD
Impact of the CTD
Understand the impact of the CTD on your Variation dossier
Variation procedures
Variation procedures
Streamline your Variation procedures for international applications
Type II variations
Type II variations
Tackle the challenges of type II Variations under the MRP
Who is this course for?
This course will be beneficial to Regulatory Affairs personnel who take part in filing variations such as:
- Regulatory Affairs
- Dossier registration department
- Product Information
- RA compliance
- Personnel from other disciplines who have an impact on the process of filing Variations, such as manufacturing, development, clinical safety and pharmacovigilance.
CPD Certified
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.
