En bref :
This 3-day training course focuses on drug development of biopharmaceuticals and provides an overview of the process from the research and development stages through product launch and post-marketing.
The training will be delivered as presentations on individual topics, interspersed by case studies and conclude with an outlook on further developments.
This 3-day training course focuses on drug development of biopharmaceuticals which have become a pivotal point of pharmaceutical innovation and currently represent 30% to 50% of newly authorised medicinal products.
Participants learn about the legislative and regulatory framework for biopharmaceuticals in Europe and the roles of the European Medicines Agency and National Competent Authorities in market access. This covers the clinical trial stage, licensing and the life-cycle of these products. Specific development paths will be delineated, such as those for biosimilars and ATMPs, the latter comprising somatic cell therapies, gene therapies and tissue engineered products.
The scientific basis and data requirements for dossiers at different stages of development will be communicated for the quality, preclinical and clinical parts of regulatory submissions. Case-studies will be inserted for the practical application of knowledge gained.
Learnings:
- Regulatory pathways for scientific advice, clinical trials and marketing authorisations of biopharmaceuticals
- Definition and characteristics of biopharmaceuticals
- Modules 3, 4 and 5 of the EU Common Technical Document (CTD) of biopharmaceuticals
- Biosimilar medicinal products
- Topics of particular relevance to biopharmaceuticals such as comparability, immunogenicity, adventitious safety, bioassays, combination products
- ATMPs
Objectives:
- Identify the relevant stakeholders and pathways of the EU regulatory framework
- Understand the necessary steps and unique requirements in biopharmaceutical development
- Identify the key quality issues specific to biopharmaceuticals, including implications of changes in the manufacturing process
- Identify the required documentation for the non-clinical part of dossiers
Venue Details: Mercure Paris La Défense Grande Arche, 17/20 Esplanade Ch. de Gaulle - Rue des Trois Fontanot, Paris 92000, France.
Category: Classes / Courses | Professional Training | Classes, Courses & Workshops.
Price:
Standard: EUR 2025.
