Dublin, May 07, 2026 (GLOBE NEWSWIRE) -- The "Pharmaceutical Development of ATMPs (Sept 28th - Sept 29th, 2026)" has been added to ResearchAndMarkets.com's offering.
Professionals in the field of biopharmaceuticals are invited to join our in-depth course focused on the regulatory, quality, and GMP requirements essential for the development of Advanced Therapy Medicinal Products (ATMPs). This course is meticulously curated to equip participants with the knowledge and skills necessary to navigate the complex landscape of ATMP development.
Led by industry experts, the course delves into the intricacies of the regulatory framework and classification of ATMPs. Participants will gain insights into overcoming the unique quality and GMP challenges presented by ATMPs, as well as the distinct differences from conventional therapies. The course also emphasizes the critical requirements for clinical trials, including the detailed preparation of the Investigational Medicinal Product Dossier (IMPD).
A significant focus will be placed on the intricate transportation needs of ATMPs, ensuring product integrity and compliance with stringent standards. This course provides practical strategies to address these challenges, ensuring the safe and effective delivery of ATMPs from manufacturing to administration.
This curriculum affords 12 Continuing Professional Development (CPD) hours, making it an invaluable opportunity for professionals striving to enhance their expertise and maintain compliance with evolving industry standards. The course is ideal for those involved in regulatory affairs, quality assurance, and anyone tasked with ensuring the integrity and compliance of ATMPs throughout their lifecycle.
Stay informed on the latest industry practices and regulatory requirements by participating in this comprehensive course. Secure your position as a leader in the ATMP sector by acquiring essential knowledge and practical skills from seasoned experts. Gain a competitive edge in your professional journey and contribute to the advancement of next-generation therapeutics.
Enroll today to ensure your readiness in an ever-changing regulatory environment, and align with the forefront of innovation in ATMP development. This opportunity provides not only an enhancement of one's professional capabilities but also contributes significantly to the advancement of the field itself. Ensure your proficiency in the dynamic sector of ATMPs by engaging with this unparalleled learning experience.
Who should attend:
- R&D personnel involved in research on cell or gene-based therapies
- Managers involved in the development and manufacture of ATMPs
- Quality assurance and quality control personnel responsible for quality aspects of ATMPs
- GMP managers responsible for implementing GMP in ATMP manufacture
- Regulatory personnel involved in inspections of ATMPs
Key Topics Covered:
- Day 1
- Introduction to ATMPs
- The Regulatory Landscape
- Strategic Considerations
- Insight into Global Regulations and Requirements
- Overcoming Quality Challenges
- Understanding Clinical Trials
- Risk-Based Approach for ATMPs
- Day 2
- GMP for ATMPs
- Stability and Logistics
- Clinical Trial Considerations
- Practical Considerations for the IMPD
Speaker
Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services, where he was head of a team of internal and external regulatory affairs consultants.
He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He had 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs.
He has over 30 years' pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.
He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities.
For more information about this training visit https://www.researchandmarkets.com/r/b48c0b
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