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Speciality and Complex Generics 2026

Conference Dates

19-11-2026 to 20-11-2026

Conference Agenda

Regulatory Strategy & Market Access
Complex Oral Products — Formulation & Design
Complex Ophthalmic Products — Formulation & Design
Transdermal Products — Formulation & Design
Nasal Products — Formulation & Design
Analytical & Characterization Science

Regulatory Strategy & Market Access
- Comparative regulatory pathways: US (ANDA 505(j) vs 505(b)(2)), EU (hybrid Art 10(3), biosimilar Art 10(4)), and India's CDSCO framework — alignment and divergence across the three
- India's complex generics landscape: policy support (PLI schemes, manufacturing investment) and case studies of successful complex generic launches in the US/EU
- Patent and IP strategy: Paragraph IV litigation, method-of-use and device patents, and designing non-infringing formulation/device architecture
- Regulatory intelligence and harmonization: FDA Product-Specific Guidances and patent expiry tracking as early opportunity signals; EMA-FDA parallel scientific advice pilot; EU member-state divergence in hybrid application review
Complex Oral Products — Formulation & Design
- QbD applied to oral complex generic development
- Complex oral suspensions and liquids: particle engineering and polymorph control
- Abuse-deterrent oral formulation technologies
- Complex oral solid formulation design: oral NBCDs (sevelamer, iron-carbohydrate complexes), modified/extended-release systems, ODTs, multiparticulates, and complex fixed-dose combinations
Complex Ophthalmic Products — Formulation & Design
- Device/dropper design: tip geometry, drop size/volume consistency
- Sterility assurance and preservative efficacy considerations
- Preservative-free and multi-dose ophthalmic formulation design
- Formulation design for ophthalmic suspensions, emulsions, and gels: including particle size and polymorphic form control — impact on ocular residence time and irritation
Transdermal Products — Formulation & Design
- Transdermal delivery system architecture: drug-in-adhesive vs reservoir vs matrix systems, including adhesive selection and patch construction
- Used-patch residual drug and abuse-deterrence considerations for controlled substances
- Navigating device/patch design patents: non-infringing architecture
- Permeation enhancer selection: efficacy vs irritation/sensitization trade-offs
Nasal Products — Formulation & Design
- Nasal-to-systemic vs locally-acting nasal products — divergent design goals
- Deposition and mucociliary clearance considerations in formulation design
- Actuator/device selection and design for nasal sprays
- Nasal spray formulation design: suspension vs solution systems
Analytical & Characterization Science
- Advanced analytical tools and cross-regional method validation
- Dissolution and drug release method development for complex oral and semisolid products
- Dosage-form-specific performance testing
- Q1/Q2/Q3 sameness and physicochemical characterization

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Registration

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