(Invited speakers and poster presentations)
Keynote Speakers: Yesterday – Today – Tomorrow:
- Regulatory perspectives
- Industry perspectives
- Patient/Pharmacy perspectives
New Trends in Pharmaceutical Sciences:
- From small molecules to large molecules and the complex drugs
- Biological complex drugs and Non-biological complex drugs (NBCDs)
- Clinical pharmacology and clinical pharmacy
- Regulatory sciences
Complex Drugs Including Nanomedicines:
- Landscape of complex drugs
- Scientific challenges in biological and non-biological complex drug
- Topicals, transdermals and drugs with special bioequivalence problems
Biologicals and Biosimilars:
- Biosimilars with evolving complexity
- Biosimilars in clinical use: challenges
- Advances in peptides
Regulatory Perspectives:
- FDA: Nanomedicines approval
- EMA: Equivalence approach: non-clinical and clinical aspects
- One global medicine: ICH/WHO: harmonisation of regulatory sciences
- Substitution and interchangeability
(Non-Biological) Complex Drugs and Similars:
- Why NBCDs are special?
- Colloidal (nano-particle) i.v. iron product
- Liposomes
- Challenges in determining and defining bioequivalence
Drug-Device Combination Products:
- Regulatory requirements for drug-device combination products
- The practical consequences of the new Medical Device Directive
Advances in (Bio)Analytical Testing:
- Advances in bioanalytical techniques and LC-MS/MS
- Analytical challenges for complex drug products and characterizing nanoparticle drugs
- Analytical toolbox for proteins: moving to full characterization
- Critical quality attributes: just an analytical challenge?
Advances in Dissolution/Drug Release:
- Dissolution in biorelevant dissolution media
- Drug release from novel dosage forms
- Complexity involved in drug release from nanomedicine: a complex scenario
Aspects of Nanotechnology:
- Nanosimilars and impact on drug selection
- Sustained-release nanocrystals and nanofibers in drug delivery
- Nanotechnology, nanobiotechnology in targeted drug delivery
- Nanomedicines in clinical practice: critical aspects to consider
COVID-19 – Opportunities and Challenges of Vaccine Development:
- Advances in new vaccines and peptides
- Academic approach to vaccine development in a global pandemic
Biodegradable Polymers:
- Development, technological, analytical, regulatory and clinical aspects
- New possibilities of biodegradable polymers
Panel Discussion:
- Controversial issues
- Global harmonisation
- Impact of complex drugs on clinical use of drugs
- New possibilities of vaccine development