Pediatric and Geriatric Pharmacology

Drug development for pediatric and elderly populations presents unique scientific and ethical challenges. This session begins with the fundamentals of age-related pharmacokinetics and pharmacodynamics that influence dosing and efficacy. Speakers will cover formulation challenges such as taste-masking for children or ease of swallowing for older adults. Experts will discuss innovative delivery forms like mini-tablets, oral films, and transdermal patches suited for these groups. Clinical trial design for vulnerable populations will be addressed, including ethical consent/assent procedures, age-specific endpoints, and long-term safety monitoring. Regulatory frameworks like the Pediatric Research Equity Act and EMA’s Paediatric Investigation Plans will be explained.

Specific diseases with pediatric/geriatric focus—such as neurodegenerative conditions, pediatric cancers, and rare syndromes—will be used to illustrate drug development approaches and challenges. Attendees will better understand the scientific and regulatory complexities of designing age-appropriate, safe, and effective treatments that meet the needs of these growing patient segments.

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