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June 26, 2019
NDA

Pediatric Development – Regulatory Aspects in EU and US

With 20 years of experience from regulatory science, Daniela Gerl and Dr Isabel Schemainda will provide tangible and actionable advice into the requirements for an optimised pediatric strategy.

Pediatric Development – Regulatory Aspects in EU and US

With 20 years of experience from regulatory science, Daniela Gerl and Dr Isabel Schemainda will provide tangible and actionable advice into the requirements for an optimised pediatric strategy.

-
NDA
-
June 26, 2019

Neither the EMA nor FDA will approve a new drug without the pediatric patient population having been appropriately considered.

This seminar will focus on legislative requirements and pediatric incentives available in both jurisdictions in order to maximise the rewards and avoid delays in registration.

The seminar will provide insight into:

  • The importance of preparing a global pediatric strategy early
  • How to capitalize on the incentives for pediatric research
  • How to avoid unnecessary delays in your drug development program

Presenters

With 20 years of experience from regulatory science, Daniela Gerl and Dr Isabel Schemainda will provide tangible and actionable advice into the requirements for an optimised pediatric strategy.

Agenda

09:00 Registration and complimentary breakfast
09:30 Welcome: Andrea Aschenbrenner, Director Business Development Europe
09:40 Presentation: Pediatric Development – Daniela Gerl & Dr Isabel Schemainda
10:30 Question and answer session
10:50 Concluding remarks

Take the opportunity to book a 20 min slot to speak directly with our experts.
Email munich@ndareg.com

Email: munich@ndareg.com to book your time now.

Date: 16th July 2019

Time: 09:00 – 11:00 (with the opportunity to book 1-1 meetings afterwards)

Venue: Am Klopferspitz 19a, 82152 Martinsried/Planegg, BioM Seminarraum, Munich

The seminar will be an open and interactive workshop with the opportunity to ask questions. Specific questions can be sent in advance to munich@ndareg.com

Registration: RSVP by Friday 12th July 2019 to munich@ndareg.com

Contact: Thomas Trache +49 8935 854 000

If you are unable to attend, please advise us no later than two days before the seminar.

We look forward to seeing you there!

Last updated:
July 5, 2019

NDA

Click here to read more about us!

Neither the EMA nor FDA will approve a new drug without the pediatric patient population having been appropriately considered.

This seminar will focus on legislative requirements and pediatric incentives available in both jurisdictions in order to maximise the rewards and avoid delays in registration.

The seminar will provide insight into:

  • The importance of preparing a global pediatric strategy early
  • How to capitalize on the incentives for pediatric research
  • How to avoid unnecessary delays in your drug development program

Presenters

With 20 years of experience from regulatory science, Daniela Gerl and Dr Isabel Schemainda will provide tangible and actionable advice into the requirements for an optimised pediatric strategy.

Agenda

09:00 Registration and complimentary breakfast
09:30 Welcome: Andrea Aschenbrenner, Director Business Development Europe
09:40 Presentation: Pediatric Development – Daniela Gerl & Dr Isabel Schemainda
10:30 Question and answer session
10:50 Concluding remarks

Take the opportunity to book a 20 min slot to speak directly with our experts.
Email munich@ndareg.com

Email: munich@ndareg.com to book your time now.

Date: 16th July 2019

Time: 09:00 – 11:00 (with the opportunity to book 1-1 meetings afterwards)

Venue: Am Klopferspitz 19a, 82152 Martinsried/Planegg, BioM Seminarraum, Munich

The seminar will be an open and interactive workshop with the opportunity to ask questions. Specific questions can be sent in advance to munich@ndareg.com

Registration: RSVP by Friday 12th July 2019 to munich@ndareg.com

Contact: Thomas Trache +49 8935 854 000

If you are unable to attend, please advise us no later than two days before the seminar.

We look forward to seeing you there!

Last updated:
July 5, 2019

NDA

Click here to read more about us!