ICH Q9(R1): Guidelines on Pharmaceutical Risk Management
Delivery Mode: Webinar
An introduction to the ICH Q9(R1): Guidelines on Pharmaceutical Risk Management. This lesson covers the fundamentals for assessing and mitigating risks during drug product lifecycles and incorporates the latest requirements from ICH Q9(R1), which was updated in 2023, and supports and sets the foundation for a safety and quality-centric approach. By integrating with other ICH standards, it sets the foundation for a safety and quality-centric approach.
CEUs are provided once you achieve an 80% passing grade and complete the evaluation.
The course is self-paced. On average, the time required for completion ranges from 1 to 3 hours.
Included in the Regulatory CMC Essentials Certificate Program
The Regulatory CMC Essentials Certificate is a comprehensive, competency-based training program designed to build foundational expertise in global pharmaceutical quality and Chemistry, Manufacturing, and Controls (CMC) regulation. Centered on the International Council for Harmonisation (ICH) Q6–Q10 and Q12 guidelines, this certificate provides learners with the critical, foundational knowledge required to navigate quality expectations across the product lifecycle including using the science and risk-based approach—from development and manufacturing to change management and continual improvement. Learn More and Register
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Benefits include:
Online access to select ISPE Good Practice Guides that will help you learn how to practically implement best practices and principles
Member-only discounts on Guidance Documents, Conferences, and Training
Pharmaceutical Engineering® magazine
Communities of Practice access to pharma professionals in specific topics from around the world
ISPE training is priced using Global Access Pricing, a four-tier model designed to reflect what a course actually costs in your country, not just what the US price converts to.
Because course fees vary, tiered rates are applied as a percentage of the standard US price. Your rate is calculated automatically at registration based on your country, and applies to both member and non-member pricing.
Global Pricing is only for Instructor Led Training.
Tier
Member
Non-member
Tier 1
Standard pricing
Standard pricing
Tier 2
US$ 620
US$ 805
Tier 3
US$ 454
US$ 575
Tier 4
US$ 300
US$ 345
Example: Rates shown are based on a course listed at US$ 2,000 for members and US$ 2,300 for non-members. Actual amounts vary by course.
