Dublin, Nov. 13, 2026 (GLOBE NEWSWIRE) -- "ICH Q12: Advanced Pharmaceutical Product Lifecycle Management in Practice (Jan 18th - Jan 19th, 2027)" has been added to ResearchAndMarkets.com's offering.
This 12-hour ICH Q12 training course examines the harmonised framework for managing post approval CMC changes predictably and efficiently throughout the commercial product lifecycle. It focuses on applying risk and science-based approaches within an effective Pharmaceutical Quality System (PQS), enabling organisations to support regulatory compliance, operational flexibility and continual improvement.
The course provides a structured examination of the practical tools and regulatory enablers introduced by ICH Q12. Core topics include risk-based categorisation of changes, Established Conditions (ECs), Post Approval Change Management Protocols (PACMPs) and the Product Lifecycle Management (PLCM) document. Delegates will consider how these elements interact with regulatory assessment, inspection expectations and internal pharmaceutical quality processes.
Emphasis is placed on translating ICH Q12 principles into real-world execution. Delegates will explore how to define ECs without 'over locking' the dossier, ensuring that essential regulatory commitments are appropriately identified while retaining suitable lifecycle management flexibility. The course also addresses the role of product and process knowledge in determining proportionate reporting categories for post approval CMC changes.
Detailed consideration is given to the development and implementation of PACMPs. Delegates will examine how to structure protocols that clearly present the proposed change, supporting data requirements, acceptance criteria and implementation strategy. This approach can facilitate more predictable regulatory evaluation and provide an agreed pathway for managing specified future changes.
The course also examines the preparation and maintenance of the PLCM document as a central component of lifecycle management. Discussion will cover the alignment of ECs, reporting categories, PACMPs and associated commitments, with particular attention to maintaining accurate, controlled and inspection ready documentation. Delegates will assess how these lifecycle tools can be incorporated into established change management and governance processes.
Key course topics include:
- ICH Q12 principles for post approval CMC change management
- Application of risk and science-based decision-making across the commercial lifecycle
- Integration of ICH Q12 requirements with an effective PQS
- Identification and justification of Established Conditions
- Selection of reporting categories based on risk, knowledge and regulatory expectations
- Design of robust and approvable Post Approval Change Management Protocols
- Development and maintenance of the Product Lifecycle Management document
- Connections between regulatory assessment, change management and inspection readiness
- Governance of lifecycle documentation and regulatory commitments
- Use of ICH Q12 tools to support continual improvement
By completing the course, delegates will strengthen their ability to evaluate post approval changes, document regulatory strategies and apply lifecycle management tools consistently. The programme is relevant to professionals involved in regulatory affairs, CMC, pharmaceutical quality, manufacturing, technical operations, product lifecycle management, quality assurance and change control.
The training supports a coordinated approach across regulatory, quality and technical functions. It enables delegates to identify opportunities for greater predictability in change implementation while maintaining regulatory oversight, product quality and compliance with approved requirements.
CPD Hours: 12
Who Should Attend:
- Regulatory affairs and submission authors
- Quality assurance and pharmaceutical quality system owners
- Change control leads and QRM specialists
- MS&T, tech transfer, process development teams
- Analytical development, quality control, method lifecycle owners
- Supply chain, external manufacturing management specialist
- Quality agreements owners
- Program lifecycle management leads for marketed products
Speakers
Paul Palmer
Paul R Palmer is a Director / Pharmaceutical Consultantanda practicing EU / UK Qualified Person.Hehas over 35 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical devices.
Throughout his career, Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerised systems, as well as the facilities and services to support each.
People and systems have always been a core focus, how to ensure best use, optimise and enhance efficiency. He has a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.
Paul studied psychology as part of his MSc in 1993 and has always enjoyed observing the world around him with a curiosity that is rarely satisfied.
Farah Nadeem
Farah Nadeem is an Operations Manager at Paul R. Palmer Limited/ Pharmaceutical Consultant and a Trainee Qualified Person. Farah is a Pharmacist and recognised QA expert and has over 20 years of experience in the Pharmaceutical industry in the development, manufacture and supply of medicinal products.
Throughout her career, she has held various quality assurance roles and actively pursued new opportunities to expand her knowledge and expertise. As a result, she has gained a comprehensive understanding of manufacturing, storage, and distribution processes, as well as the facilities and services that support them. Involved in documentation management: writes, reviews, and audits SOPs and QMS implementations. Assists companies in meeting regulatory requirements.
In her current role as a QA Operations Manager for a Pharmaceutical Consultant Company, Farah Nadeem provides various solutions, including assistance in obtaining the first MIA(IMP) and MIA licenses, as well as preparation and hosting for regulatory inspections. Her work involves collaborating with Paul Palmer to offer services such as QP declarations for API manufacturers, regulatory inspection hosting, commercial and clinical batch release, compliance audits, and coaching and training in GxP.
For more information about this training visit https://www.researchandmarkets.com/r/tuj95j
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