The Changing Paradigm of Regulatory Submissions: Embracing Automation, Gen AI, and Innovation for Faster Approvals
Cell and Gene Therapy Clinical Trials: How to Successfully Operationalize a Trial of Prolonged Duration
Translational Clinical Pharmacology in Cell and Gene Therapy
Sample Size Re-Estimation: Risk Mitigation at the Planning Stage
Clinical Pharmacology Studies to Support Filing Packages and Labeling
Risk Assessment of Novel Neurotherapeutics: Mechanistic Translation of Preclinical Safety and PK/PD Data to a Clinical Setting
Efficient Clinical Programs and Decision Making Through Model-Informed Drug Development (MIDD)
Pediatric Clinical Trials: Tackling Clinical and Therapeutic Development Challenges Head-On
More than Skin Deep: Considerations for Dermatology and Drugs Administered to the Skin
PBPK Modeling for Pediatric Drug Development
Benefits of Bayesian Dose Escalation Designs for Oncology Studies
Risk Assessment: Traditional and Novel Approaches to Assess and Manage Risks
Inspection Readiness: What is it, why it matters, and what you need to know to be prepared
Navigating Regulatory Strategies for Cellular & Gene Therapies
Roadmap To Marketing Authorisation in Europe: Taking All the Right Turns
Webinar | Pharmacogenomics and Pediatric Drug Development: When Are Children Not Little Adults and Why?
Next Generation Strategies for Orphan Drug Development
The Challenges of Cancer Immunotherapy Development and Ensuring Durability of Response
The Value of Orphan Drug Designation in your Drug Development Program
Future Proofing Inflammatory Bowel Disease Diagnosis & Clinical Trials
Advancing Cancer Vaccines to Move to the Forefront of Immunotherapy
Pre-Anticipation: Anticipating Obstacles to Approval Before Phase I in Oncology Drug Development
Maintaining Momentum: Applying Recent Regulatory Guidance in the Midst of the Coronavirus
Enrollment, Enrichment, and Monitoring Strategies to Accelerate Phase 3 Clinical Trials in NASH
How Feasible is Feasibility in Clinical Trials?
Getting your ducks in a row: Successful Management of Large eCTD Submissions
Mind the Gap(s): Early Identification of Issues is Key for a Successful NDA or BLA