Main Scientific Topics of the DDRS 2021

(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