Global Regulatory Strategies Across Drug Development and Commercialization

About the course

Are you ready to take your regulatory competence to the next level? This 2 day course equips you with the strategic mindset, frameworks and practical tools needed to drive regulatory impact across the entire drug lifecycle – from development to approval but also through the commercialization phase. Whether you work in an R&D organization or a marketing company, you will strengthen your ability to influence cross functional decisions, shape regulatory strategy and contribute meaningfully to your company’s long term success. The focus is however on regulatory strategies during drug development. The course is given in English.

Who should attend?

This course is recommended for senior Regulatory Affairs Managers who seek strategic competence. We recommend having knowledge or experience equivalent to Läkemedelsakademin’s Basics of Regulatory Affairs at the least, to fully understand and benefit from the course. The course is also useful for other leadership roles in the pharmaceutical industry who wish to get an overarching understanding of regulatory strategic aspects and how they may impact business outcomes positively or negatively.

Learning objectives

• Knowledge of the regulatory strategic and tactical considerations for the different phases of drug development, before and after product approval, on a global level, with an emphasis on Europe and US.
• Understanding of key concepts and considerations in regulatory strategies to be able to support drug development, ensure timely regulatory approvals and optimized product labels.
• Competence to contribute in building a regulatory strategy for a product and to provide regulatory support/advice during the different phases of drug development and during commercialization.

Course outline

• The Regulatory Affairs role – a strategic partner
• Global regulatory strategies, including case study
• Strategies for EU, US, Japan and China respectively, including case study
• Paediatrics
• Orphan drugs
• Patent and exclusivity – what is the difference?
• Expedited/Fast track-procedures in the EU and US
• Authority consultations
• CMC strategies
• Health Technology Assessment and Market Access
• Regulatory and Business Intelligence
• The Regulatory Affairs role in a cross functional team