Pharma & Biotech

        drug device combination products regulatory quality requirements

        Drug-Device Combination Products: Quality & Regulatory Requirements (US Edition)

        6. June 2023

        CMC Regulatory Compliance for Biological Drug Products

        12. June 2023
        Quality Requirements for Solids

        Quality Requirements for Solids

        12. June 2023
        Development of Solid Generic Formulations online course

        Development of Solid Generic Formulations

        12. June 2023
        process validation scale-up biologics training

        Process Scale-up, Validation and Technology Transfer for Biologics

        19. June 2023
        Pricing and Market Access of ATMPs online training

        Pricing and Market Access of ATMPs

        19. June 2023
        statistics

        Statistical Methods Across the Product/ Process Lifecycle

        19. June 2023
        Bioequivalence and IVIVC training course

        Bioequivalence and IVIVC

        22. June 2023
        Future-proofing Orphan Drug Strategies for Europe online training

        Future-proofing Orphan Drug Strategies for Europe

        26. June 2023
        paediatric clinical trials training EMA FDA regulatory guidance

        Paediatric Drug Development & Clinical Trials

        29. June 2023
        clinical investigation evaluation medical device

        Clinical Investigations and Evaluation for Medical Devices

        13. September 2023
        bioassay

        Development and Validation of Bioassays

        19. September 2023
        Extractables and Leachables

        Extractables and Leachables Control Strategies

        25. September 2023

        CMC Regulatory Compliance for ATMPs

        27. September 2023
        Advancing Real-World Evidence Generation for Causal Inference online training

        Advancing Real-World Evidence Generation for Causal Inference

        2. October 2023
        quality requirements for biologics

        Quality Requirements for Biologics

        4. October 2023
        Manufacturing of mRNA-Based Therapeutics

        Manufacturing of mRNA-Based Therapeutics

        4. October 2023
        Mitigating Immunogenicity Risk

        Mitigating Immunogenicity Risk

        10. October 2023
        ANNEX 1

        EU GMP & PIC/S Annex 1 Challenges & Solutions to Compliance

        10. October 2023

        Clinical Trial Design & Quality

        12. October 2023
        CMO Contracting, Oversight and Value Optimisation

        CMO Contracting, Oversight and Value Optimisation

        23. October 2023
        Process Scale-up, Technology Transfer and Process Validation course applying QbD principles.

        Process Scale-up, Validation & Technology Transfer

        23. October 2023

        Drug-Device Combination Products: Notified Body Opinion Process

        30. October 2023
        Aseptic Fill & Finish of Biologics & ATMPs online training course

        Aseptic Fill & Finish of Biologics

        5. December 2023

        CMC and Regulatory Requirements for Inhalation Drug Products

        Aseptic Processing

        Aseptic Processing in Manufacture of Sterile Products & ATMPs

        Project Management for Generics

        Viral Safety for Biologics online training course for pharmaceutical professionals

        Viral Safety for Biologics

        Online training providing practical insights into injectables

        Process Scale-up & Tech Transfer for Injectables

        Pharma & Biotech Stability Testing

        Pharma & Biotech Stability Testing

        Orphan Drugs Clinical Trials - Live Online Training

        Orphan Drugs Clinical Trials

        Value Added Medicines training for business development professionals

        Value Added Medicines / Scientific, Regulatory and IP Analysis

        Pharmaceutical Cleaning Validation online training course

        Cleaning Validation in Pharma

        Analytical Method Development and Validation

        Development of Gene and Cell Therapy Training

        Accelerating Development of Gene & Cell Therapy

        This training course integrates the in-vitro dissolution testing, equipment requirements, quality control aspects and using dissolution to obtain biowaivers.

        Dissolution Testing, Equipment Requirements, Quality Control & Biowaivers

        Pharmaceutical Quality: QRM, CAPA & Root Cause Analysis

        GMP and Validation for Equipment Suppliers

        Development of Generic Solid Immediate Release Dosage Forms / Formulation and Analytical Method Development

        Leverage patient-centric Real-World Evidence (RWE) to accelerate the patient and market access

        Real-World Evidence in Rare Diseases: Accelerating Market Access

        Stability Testing of Biological Drug Products

        ATMP Clinical Trials – The Medicinal Product Life Cycle & Regulation

        Pharmaceutical Data Integrity

        Pharmaceutical Data Integrity

        Clinical Outcome Assessments and PROs

        Clinical Outcomes Assessments and PROs

        Change Management

        Change Management for Medical Affairs

        GMP in API Production

        Good Manufacturing Practices in API Production: How to Implement ICHQ7

        process and equipment change

        Process and Equipment Change Management

        Pharma Marketing

        Pharma Marketing Excellence

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