Main topics of the Symposium

Complex Drugs including Nanomedicines:

  • Landscape of complex drugs
  • Scientific challenges in biological and non-biological complex drug

Industry Perspectives

  • Innovations into practice
  • Challenges of the pharmaceutical industry
  • Development of a new chemical entity Nanomedicines: an industry view

Regulatory Perspectives

  • FDA: Nanomedicines from discovery to approval
  • EMA: Equivalence approach; non-clinical aspects
  • Regulatory pathways for biosimilars: FDA, EMA approach

Biologicals and Biosimilars

  • Biosimilar landscape
  • Evaluation of monoclonal antibodies developed as biosimilars
  • Clinical aspects: Substitution, interchangeability
  • Biosimilars: Case study – Filgrastim

(Non-Biological) Complex Drugs and Similars

  • What are NBCDs and what makes them special? Iron sucrose complex Complexity of iron carbohydrate drugs and their evaluation
  • Liposomes
  • Ophthalmic drug products
  • Challenges in determining BE
  • Copaxone follow versions

Advances in (Bio-)Analytical Testing

  • New perspectives in bioanalytical techniques and LC-MS/MS
    (sensitivity, selectivity, specificity, column technology, etc.)
  • Analytical challenges for complex drug products
  • Advances in bioanalytical techniques
  • Challenges in characterizing nanoparticle drugs Analytical toolbox for proteins: moving to full characterization
  • Critical quality attributes in analytics

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
  • Dissolution / Drug release of nanomedicines

Bioequivalence

  • Biomarker and its challenges
  • Update on harmonization

Aspects of Nanotechnology

  • Liposome formulations
  • Sustained release nanocrystals
  • Nanofibers in drug delivery
  • Nano pharmaceuticals
  • Nanobiotechnology
  • Nanotechnology in targeted drug delivery
  • Nanomedicines in clinical practice: Critical aspects to consider

Biodegradable Polymers

  • Development, technological, analytical, regulatory and clinical aspects