Explore our range of 1, 2 and 3-day courses covering the industry spectrum for your department - learn about best practices to increase success rates for new drug submissions globally and enhance efficiency across your business.
Gain a strategic insight into the EU regulatory framework and learn how to improve your dossier compilation process.
Learn how to overcome the challenges presented by continued changes to European regulatory affairs.
Learn how to compile this important section of your dossier to ensure faster turnarounds of submissions.
Expedite EU drug registration by integrating regulatory requirements in drug development.
Learn how to maintain compliant and ethical clinical trials in the context of the new Clinical Trials Regulation.
Acquire a practical understanding of the regulatory challenges, manufacturing concerns and clinical trial preparation for ATMPs.
Avoid substantial fines for non-compliance with GDPR and protect your company's reputation.
Learn to apply project management techniques to streamline your regulatory procedures.
Takeaway an in-depth analysis of the regulatory environment so you can more confidently prepare new drug applications (NDAs) dossiers.
Learn how to manage regulatory developments in the region.
Ensure speedy regulatory approval and guarantee your filing variation procedures are cost-effective.
Understand regulatory and medical factors surrounding the requirements for optimal product information.
Gain a practical insight into everything from simple risk assessment techniques to risk mitigation at an advanced level.
Learn the key aspects of RIM and the new IDMP standard so you can build an effective strategy and meet IDMP deadlines.
Discover practical solutions for managing global regulatory requirements and new challenges.
Further your understanding of regulatory affairs in the MENA region in order to build a strategic roadmap for bringing new products to market.
Learn the key factors of successful of drug/device combination products to ensure a more efficient approval process.
Gain a strategic insight into the key requirements for developing generics from a global perspective.
An essential overview of regulatory requirements to ensure successful strategies for gaining market access in the CIS.
Gain a comprehensive understanding of the regulations surrounding the authorisation of veterinary medicinal products in the EU to enable fast product approval.
Our online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.
Gain a comprehensive understanding of the EU regulatory framework and explore strategies for dossier application to ensure speedy approvals.
Learn to analyse, prepare and construct the intricate details of Module 3 of your dossier to ensure a more efficient submission process.
Examine key regulatory and data requirements for the practical application of biowaivers in the EU and US.