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Biosimilars FORUM

Biosimilars challenges - the EU, the US & the ICH region This seminar gives you a thorough update on the challenges arising in connection with the revision of the biosimilars guideline and addresses comparability exercises, bioequivalence and immunogenicity testing
  • Biosimilars challenges - the EU, the US & the ICH region This seminar gives you a thorough update on the challenges arising in connection with the revision of the biosimilars guideline and addresses comparability exercises, bioequivalence and immunogenicity testing

    We would like to give you a thorough update on the new challenges and opportunities arising in connection with the revision of the overarching biosimilars guideline and further guidelines/revisions.

    During the two-day seminar you will receive valuable information on comparability exercises, bioequivalence and immunogenicity testing, as well as in-depth information on quality issues. Further economic factors related to pricing and reimbursement will be addressed to complete the picture.

    After having attended this seminar you will be familiar with the current regulatory requirements and will have a good insight into the European, the US and further development programmes. You will know about the main development challenges and will have new ideas on how to overcome them.

    Topics:

    - Comparability exercise - the reference as a "moving target"
    - Quality issues: quality target product profile
    - Clinical testing: bioequivalence, immunogenicity
    - Sourcing of originator medication
    - Biosimilars: guidelines, current regulatory thinking and health economy

    50.11704 8.67853
Wann 02.07.2014 um 09:00 bis
03.07.2014 um 15:30
Veranstaltungsort Hilton Frankfurt Hotel
Stadt Frankfurt
Kontaktname
Kontakttelefon 06221 500 680
Zielgruppe This seminar addresses the needs of managers in the pharmaceutical industry who work with biosimilars or plan to do so in the near future.
Especially those working in the following areas will benefit from this event: marketing authorisation, clinical & preclinical trials, quality & analytics, business development and law.
Termin übernehmen vCal
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We would like to give you a thorough update on the new challenges and opportunities arising in connection with the revision of the overarching biosimilars guideline and further guidelines/revisions.

During the two-day seminar you will receive valuable information on comparability exercises, bioequivalence and immunogenicity testing, as well as in-depth information on quality issues. Further economic factors related to pricing and reimbursement will be addressed to complete the picture.

After having attended this seminar you will be familiar with the current regulatory requirements and will have a good insight into the European, the US and further development programmes. You will know about the main development challenges and will have new ideas on how to overcome them.

Topics:

- Comparability exercise - the reference as a "moving target"
- Quality issues: quality target product profile
- Clinical testing: bioequivalence, immunogenicity
- Sourcing of originator medication
- Biosimilars: guidelines, current regulatory thinking and health economy

Direktbuchung

Weitere Informationen über diesen Termin…

FORUM Institut für Management GmbH

Programm

1407231.pdf — PDF document, 362 kB (370,996 bytes)