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 nanomedicines: an industry view

Regulatory Perspectives

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

Biologicals and Biosimilars

• Biosimilar landscape
• Evaluation of monoclonal antibodies biosimilars
• Clinical aspects: Substitution, interchangeability

(Non-Biological) Complex Drugs and Similars

• What are NBCDs and what makes them special?
  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
• Analytical challenges for complex drug products
• Advances in bioanalytical techniques
• Challenges in characterizing nanoparticle drugs analytical toolbox for proteins
• 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

• Update on harmonization

Aspects of Nanotechnology

• Liposome formulations
• Nanofibers in drug delivery
• Nanopharmaceuticals
• Nanobiotechnology
• Nanotechnology in targeted drug delivery
• Nanomedicines in clinical practice: Critical aspects to consider

Biodegradable Polymers

• Development, technological, analytical, regulatory and clinical aspects