Immunogenicity and Biosimilarity

Immunogenicity and Biosimilarity

Annual Biopharmaceuticals Meeting 2013 - Thomas Schreitmüller
Description: 24 Minutes

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Dr. Gabriele Dallmann, Study Director
Event Manager

Zsuzsanna Nandori, Event Manager
Jutatstraße 26
80636 München

Tel.:+49 (0) 89 44 23 5997

Module 1 of the CTD

Seminar 1: European Pharmaceutical Regulatory Environment - Lidia Cánovas

  • Application form
  • Application numbering
  • Multiple applications: co-marketing and co-promotion
  • Strengths
  • Fees and reduced fees
  • Proposals (Mock-ups) for packaging, labelling and package inserts
  • Specimens
  • INN
  • ATC codes
  • Environmental Risk Assessment (ERA)

Length: 86 min
plus 19% VAT
Access time 2 day(s)
Back to all presentations of seminar 1.

The Speaker:

Lidia Cánovas has a degree in Pharmacy from the University of Barcelona and is currently the General Manager - Commercial of Asphalion, S.L., consultancy company to which she associated in 2003.

Her main activities focus on consulting and strategic direction of projects in the area of Regulatory Affairs and Development for Europe and USA, actively participating in scientific advice, Paediatric Plans, Orphan Drug Designations, Development Plans, Centralized procedures, decentralized and mutual recognition in permanent contact with the regulatory authorities. She also has extensive regulatory experience in innovative, biological, biotech and advanced therapy.

She previously held positions in the pharmaceutical industry as Director of Regulatory Affairs, Vice-Director of R&D and Technical Director (Qualified Person).

More information on the seminar.