Lunch & Learn: Regulatory Strategy – Enabling Successful Drug Development

4 apr '17
Tid
11:45 - 12:30
Plats
Restaurant Inspira Medicon Village, Scheelevägen 2, Lund
Arrangör
Rhovac and Medicon Village

This Lunch & Learn is targeting CEOs, CSOs, or CMOs from Small biotech companies or academia with ideas that are moving into preclinical phase. How do you increase the chance of success of your projects by proactively using a Regulatory Strategy from early on in development?

Regulatory Consultant at BioTrack ApS, Ann Christine Korsgaard, and CEO at RhoVac AB, Anders Ljungqvist, will discuss regulatory considerations and opportunities primarily in early stage development.

Participants will learn about:

  • The value of a Regulatory Strategy and why it is worthwhile early on
  • The many options of Agency Interactions in EU and US and benefits of them
  • High level content of a Regulatory Strategy
  • The regulatory approach RhoVac used to obtain approval for first-in-man clinical study one years after starting regulatory toxicology studies.

Ann Christine Korsgaard, Biotrack ApS: +25 years’ regulatory experience from biotech, small- and big pharma, face to face meetings with Regulatory Authorities (FDA, EMA and National Authorities) and from lecturing.

Anders Ljungqvist, RhoVac AB: +35 years’ experience in product development from biotech and from big pharma.

 

Lunch & Learn är ett återkommande evenemang och är öppet för alla.  Eventet arrangeras av någon av Medicon Village medlemsorganisationer och/eller tillsammans med större nätverksorganisationer (värd). Deltagare köper sin lunch i restaurangen och tar den med sig till nedre delen av restaurangen. Föredraget börjar denna gång ca 11.45. Passa på att lära dig något nytt som du har nytta av i ditt arbete eller privatliv!