New European Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms

15. Juni 2015 - 16. Juni 2015
Translational Approaches, Bonn

Save the date announcement for a brand new workshop!

The development of modified release formulations still is a challenge for applicants and authorities as well. From ‚which studies are needed when‘ to ‚how to optimize the study design‘ – a broad variety of scientific and regulatory aspects need to be considered for new modified release forms of new chemical entities and known drugs, but also for abridged applications.

The new European Guideline has brought some changes and also some clarification especially with regard to orally administered drugs. The first day of this workshop is intended to adress specifically the new requirements regarding oral formulations.

The second day will focus on patches regarding the PK studies necessary but also of course patch adhesion trials and skin irritation and sensitization studies.

The workshop is intended for participants from industry- and CRO side as well as for regulators and investigators involved in drug development. A group of highly experienced experts together with representatives from authorities will present the relevant aspects to be observed and will share their specific experience and knowledge with you.

The workshop has been initiated by AGAH together with the EUFEPS Network on Bioavailability and Bioequivalence.

Informationen

The new European Modified release Guideline

from cook book to interpretation – June 15 – 16, 2015 Bonn, Germany

Introduction

Rationale for the workshop

The development of modified release formulations still is a challenge for applicants and authorities as well. From “which studies are needed when” to “how to optimize the study design” – a broad variety of scientific and regulatory aspects need to be considered for new modified release forms of new chemical entities and known drugs, but also for abridged applications.

The new European Guideline has brought some changes and also some clarification especially with regard to orally administered drugs. The first day of this workshop is intended to address specifically the new requirements regarding oral formulations.

The second day will focus on patches regarding the PK studies necessary but also of course patch adhesion trials and skin irritation and sensitization studies.

The workshop is intended for participants from industry- and CRO side as well as for regulators and investigators involved in drug development.

A group of highly experienced experts together with representatives from authorities will present the relevant aspects to be observed and will share their specific experience and knowledge with you. Each presentation is scheduled with 30 Minutes maximum to allow for a minimum of 10 Minutes discussion.

The workshop has been initiated by AGAH together with the EUFEPS Network on Bioavailability and Bioequivalence.

Day 1: 15.6.2015 Monday

Time Content Lecturer
10:00 Welcome Henning Blume, Oberursel/Erfurt
10:10 Introduction into the regulatory concept Henrike Potthast
10:50 MR products developed as line extension of already approved IR formulations Henning Blume, Oberursel/Erfurt
11:30 Break
12:00 Bioequivalence of MR products Gerald Beuerle
12:40 Summarising discussion All speakers
13:00 Break
14:00 PK characteristics and statistical evaluation of BE studies: how to handle the newly introduced endpoints and how to apply adaptive designs Ralph-Steven Wedemeyer, Oberursel
14:40 Food effect studies with MR products – when and how? Barbara Schug, Oberursel/Erfurt
15:20 MR dosage forms with special release characteristics Henning Blume, Oberursel/Erfurt
16:00 Pitfalls and problems – what do we learn from the regulatories‘ experience Henrike Potthast, Bonn
16:40 Summarising discussion All speakers

Day 2: 16.6.2015 Tuesday

09:00 Welcome Barbara Schug, Oberursel/Erfurt
09:10 Biopharmaceutical properties of patches relevant for transdermal drug absorption – confounding factors and in-vitro testing Johannes Bartholomäus, Aachen
09:50 Patch development with new drugs versus generic development – principles and methods Barbara Schug, Oberursel/Erfurt
10:30 Break
11:00 How to design skin irritation / sensitization studies Walter Wigger-Alberti, Hamburg
11:40 How to realise patch adhesion studies André Warnke, Oberursel
12:20 Pitfalls and problems – what do we learn from the regulatories‘ experience Janet Schriever, Bonn
13:00 Summarising discussion All speakers

Attendance Fees Day 1 / Day 2

400€ / 200€ Non-Members
300€ / 150€ Member of AGAH, DGPharMed or DGKliPha or Junior Scientist up to the age of 30.

The participation fee is per person. Please note, according to §4 para 22 German turnover tax law, registration and workshop fees are exempt from VAT. Registration fees are charged and collected on behalf of AGAH e.v. All bookings are subject to change.

Contact

Association for Applied Human Pharmacology (AGAH) e.V.
Postfach 10 14 58
D-41546 Kaarst
Phone: +49 (0)2131-2018194
Email: info ( a t ) agah.eu
Web: www.agah.eu

Accomodation

There is a limited number of rooms reserved at Hilton Bonn. Reservation can be made in context with your workshop registration.

Programme Committee

  • Henning Blume, SocraTec R&D, Oberursel/Erfurt
  • Barbara Schug, SocraTec R&D, Oberursel/Erfurt
  • Hildegard Sourgens, München
  • Henrike Potthast, Bonn

Workshop Venue

Hilton Bonn
Berliner Freiheit 2
53111 Bonn / Germany
www.hiltonhotels.de

Registration

CSi Hamburg GmbH
Antje Blömeke | Matthias Runow
Jungfrauenthal 22 · 20149 Hamburg, Germany
Tel.: +49 40 30770 300 Fax: +49 40 30770 301
E-Mail: agah-veranstaltungen ( a t ) csihamburg.de
Web: www.csihamburg.de

15. Juni 2015 - 16. Juni 2015

New European Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms

Translational Approaches


Bonn
Deutschland

+ Google Kalender+ Zu iCalendar hinzufügen