International Initiatives on Drug Safety. Linda R. Horton Partner Hogan & Hartson LLP Brussels & Washington, DC LRHorton@HHLaw.com August 23, 2007. 3 rd Annual FDA Regulatory and Compliance Symposium Harvard University Campus, Cambridge, MA. What we will discuss today. EU Update
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Linda R. Horton
Hogan & Hartson LLP
Brussels & Washington, DC
August 23, 2007
3rd Annual FDA Regulatory and Compliance Symposium
Harvard University Campus, Cambridge, MA
Tightening Up: “First Time in Humans” Clinical Trials
Lightening Up: Biosimilars
Meds Made of Us: Advanced Therapies/Tissue-Engineering
Meds for Kids: EU Pediatrics Regulation
Truth or Consequences: EU Penalties Regulation
The EMEA is a secretariat for a network of experts.
Positive opinions from Committee on Medicinal Products for Human Use (CHMP); all with reference product Eprex/Erypo
Rejected as biosimilar (received a negative opinion from CHMP):
The continued supply issue
Liability issues for sponsors
*Paragraph 30 was added at the 52nd WMA General Assembly, Edinburgh 2000
IMPACT: WHO Initiative
EU and Council of Europe Initiatives
SOURCES OF COUNTERFEITS
Photos courtesy of Lewis Kontnik
COMBATING COUNTERFEIT DRUGS
Linda R. Horton
Hogan & Hartson L.L.P.
Brussels & Washington, D.C.