In our next EU-focused event
A short course on Regulatory Affairs with emphasis on
Biopharmaceutical Drug Substances and Products, including Biosimilars
you can learn about:
- Biological products in lay and legal terms
- The legal basis of Innovator and Biosimilar applications for EU Marketing Authorisations
- The development and life cycle of a biotechnology-derived product
- Principles and scientific issues about the analytical Quality Control of biological macromolecules
- WHO involvement both in regulation and regarding reference materials
- Specification setting
- Stability issues
- Major potential biological contamination problems
- Regulatory and quality compliance
- The importance of excipients in many biopharmaceuticals
- Quality, nonclinical and clinical issues to be addressed in the Common Technical Document (CTD)
- Label expansion and new derivative development
- Multi-site manufacture and comparability
- The scientific challenge in developing Biosimilar (similar biotherapeutic) Products
- Recent changes from the European Medicines Agency (EMA) and the European Pharmacopoeia (Ph Eur) regarding control of risk of transmissible spongiform encephalopathies (TSE)
- The looming impact in 2012 of the new legislation on falsified medicines
You can find out more by visiting http://www.pharmaqmtraining.eu/brochures/biological_drug_substances.html
HURRY TO BOOK YOUR PLACE
It may interest you to know that using the booking form you can obtain a discount on booking two delegates at a time
Please wait for confirmation before finalising your travel plans
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