Health Science Webinars

March 2024 – Overcoming Contamination Risks During Biological Production: Mycoplasma & Virus Testing March 2024 - How to Get Ready for New General USP Chapters 665 and 1665 March 2023 - Biosimilarity and Sameness Testing: Analytical Strategies to Fulfill FDA Submission Requirements June 2022 – Biosafety Testing Cell and Gene Therapeutics: Regulations, Requirements and Recommendations February 2022 – Mission Possible: Overcoming Analytical Laboratory Resourcing Challenges December 2020 - Understanding Molecules: Choosing the Right Method for Characterizing Biologics May 2020 – Control Potential Viral Contaminants in Biologics with Effective Testing April 2020 – Biosafety Considerations for Regulatory Approval of Vaccines and Biologics June 2019 – Characterization of Aggregates and Nanoparticles in Biologics

May 2023 – Regulatory Requirements and Strategies for Nitrosamine Testing February 2022 – Mission Possible: Overcoming Analytical Laboratory Resourcing Challenges January 2022 — How (2D)-LC-MS(MS) Enables Structure Elucidation of Unknown Impurities July 2021 – Nitrosamine Control: Understanding the New FDA and EMA Regulations November 2020 – Planning your Testing to Identify Unexpected Impurities in Medicines July 2020 – Nitrosamine Testing: The Regulatory Aspects July 2020 – How to Expedite the Implementation of Insourced Technical Teams in GxP Environments

May 2023 - Streamline your Drug Development Pathway from Preclinic to FIH/POC January 2023 - Lipid-Based Drug Delivery: Dosage Form Design from Preclinical to First-in-Human

April 2024 - Lungs of Tomorrow Future of Asthma COPD Treatment March 2024 - Insider Perspectives on the Clinical Trials Regulation in Early Phase Trials After One Year June 2023 - Are You Really Ready for Unblinding your Clinical Data September 2022 – State-Of-The-Art of Clinical Trial Feasibility: Finding the Right Sites and Populations for Your Clinical Trials June 2022 – The Library Approach Driving EDC Setup Efficiencies: A Case Study April 2022 – Embracing the SDTM Mindset at Study Start to Mitigate Compliance Issues March 2021 – Standard vs “Hybrid” Early Phase Trials: Advantages and Challenges November 2020 – Get Ready in One Click: Clean SDTM Datasets by Using Library Backend Rules July 2020 – Risk Based Monitoring Through COVID-19 and Beyond: Advancing Structured Flexibility May 2020 – End-to-End SDTM Automation: a Metadata Centric Approach April 2020 – CDISC Library Try-out: From Implementation to Evaluation of the API April 2020 – COVID-19 Human Challenge Trials – What Will be the Regulatory Considerations

April 2024 - Assessing Toxicological Risks of Medical Device Constituents: Principles and Procedures April 2024 - Recent Trends and Regulatory Expectations in Chemical Characterization of Medical Devices per ISO 10993-18 Guidance July 2023 - Aesthetic Dermatology - Clinical Testing of Injectables April 2023 - Atopic Dermatitis in Clinical Trials March 2021 - BPOG 2020 and USP 665 – Extractables Testing of Single-Use Systems March 2021 - Chemical Characterization of Medical Device Materials According to ISO 10993–18:2020 September 2020 – How to Achieve a Confident Identification During Extractables and Leachables Analysis March 2020 – How to Prepare a Successful Leachables Study Strategy for Complex Formulated Drug Products

Webinars & Events