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Regulatory, Developmental And Manufacturing Challenges For ATMPs

Course summary
2 days
Professional Training

Course description

Regulatory, Developmental And Manufacturing Challenges For ATMPs

This two-day course will provide you with a practical understanding of regulatory challenges, manufacturing concerns and clinical trial preparation for ATMPs.

Using case studies and relevant examples, the course will improve your understanding of the regulatory landscape and provide you with approval routes for your product. In addition, you will gain a comprehensive understanding of the principal difficulties in delivery and shipping, applying GMP in manufacturing and getting ready for clinical trial.

Delegates may choose to attend either one or both days of the course.

Suitability - Who should attend?

This course is designed for professionals interested in the area of ATMPs, or already working in it. The following departments may have a particular interest:

  • Regulatory affairs
  • Quality assurance
  • Quality control
  • Manufacturing
  • Bioprocessing
  • Clinical development

Outcome / Qualification etc.

Regulatory, Developmental And Manufacturing Challenges For ATMPs

Training Course Content

  • Consider the current regulation in Europe and globally and investigate new developments;
  • Evaluate possible regulatory avenues for your product;
  • Build on your understanding of quality control for ATMPs, including testing, oversight of materials and release;
  • Confirm GMP manufacturing standards for ATMPs and make practical preparations for inspections;
  • Reflect on common preservation and shipping issues for ATMPs and discuss using case studies;
  • Gain guidance on the Investigational Medicinal Product Dossier for an ATMP and what should be included;
  • Optimise your preparations for clinical trials

Why choose PTI

On average, delegates of their online academies said: 

Quality of content:


85% had applied content during the course to their role

Delivery rating:


About provider

PTI - Pharmaceutical Training International

PTI - Pharmaceutical Training International - Training for the Pharma Industry

PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...

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