New Insights of Biocide Product Regulation: Strategies and Perspectives of the Authorization Process Workshop
May 15, 2018 | Milan, Italy
Under the terms of the Regulation (EU) No. 528/2012, a biocidal product should contain active substances with a more favourable environmental and human health profile. To prevent undesired and harmful effects risk assessment for biocides has become a crucial part of the dossier for active substance approval as well as for biocidal product authorisation.
After the remarkable success of the past edition, Eurofins BioPharma Product Testing Italy presents a dynamic and interactive Workshop with an enriched programme exploring regulatory aspects, risk assessment and efficacy testing of biocidal products.
Click here to view the agenda and register.
View our webinar to learn how to implement an efficient testing program for assessing the biocompatibility of your combination product’s device component, which incorporates the relevant requirements of ISO 10993-1, to satisfy both U.S. and international regulatory agencies.
This presentation will include real-world case studies and best practices for:
- Chemical Characterization, including Extractables and Leachables Testing
- Toxicological Risk Assessments
- Biocompatibility Testing
- Pitfalls to avoid while developing testing plans
- Future trends for Combination Products
- Implications of new FDA guidance on the use of ISO 10993-1
- Are you Effectively Monitoring your Contract Lab?
- Eliminate the ups and downs of staffing challenges
- Practical Guidance for Successful Mammalian Cell Banking & Cell Line Characterization
- Developing a Comprehensive Tool Kit for Microbial Identification
- Navigating the Analytical Development Challenges for Bioprocess Residuals and Impurities
- Alternative Rapid Mycoplasma Testing Methods for Biopharma Products
- UV-C Treatment—a New Procedure for Viral Inactivation
- Chemistry and Microbiology Perspectives on Cleaning Validations and Disinfectant Efficacy Studies
- Best Practices for Extractables and Leachables Testing
- Effective Strategies for Managing Comparator Product Testing
- Outsourcing Cell Based Potency Assays: Perspectives from a Sponsor and a Contract Testing Laboratory
- Critical Aspects of Antibody-Drug Conjugates: Structural Characterization and Analysis
- Efficient and Effective Approaches to Managing Raw Material Methods
- Risk Management of Adventitious Agent Contamination in Biopharmaceutical Products