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REGISTRATION RATES
Early registration until April 30
SPEAKERS
850 € for Non-Member
Daniel Bucks, PhD
550 € for AGAH Member
Director of Skin Biology & Drug Delivery,
Registration after April 30 Dow Pharmaceutical Sciences, Inc., Petaluma, CA,
USA
1000 € for Non-Member
Sandra Johannsen, DVM, PhD, ERT
700 € for AGAH Member
Global Preclinical Development, Intendis GmbH, Berlin,
Germany
LOCATION
Walter Wigger-Alberti, MD
Empire Riverside Hotel
Managing Director, bioskin GmbH, Hamburg, Germany
Bernhard-Nocht-Straße 97
20359 Hamburg, Germany Professor Andrew Finlay
2-DAY WORKSHOP
Department of Dermatology, Cardiff University; Cardiff,
REGISTRATION UK
Intercom Dresden GmbH Frank Sinner, PhD
Diana Berthold Deputy Head of Institute of Medical Technologies and DERMATOLOGICAL
Zellescher Weg 3 Health Management, Joanneum Research,
01069 Dresden, Germany Graz, Austria
PRODUCT DEVELOPMENT
Telefon: +49 (0)351-320 173 80 Klaus Rose, MD
Telefax: +49 (0)351-320 173 33 Principle Consultant, Granzer Regulatory Consulting An International Workshop on
Web: www.intercom.de and Services, Munich, Germany Strategy and Regulatory Requirements
Elke Röhrdanz, PhD, ERT from Formulation through Clinical Development
ROOM RESERVATIONS Preclinical Assessor, BfArM, Bonn, Germany
Room reservations are possible at conference rates at Michelle Carpenter, JD, RAC
several hotels. Reservations can be made using the Regulatory and Clinical Affairs, Dow Pharmaceutical
registration form. Sciences, Inc., Petaluma, CA, USA
ORGANIZING COMMITTEE Charles Bon, MS
President, Biostudy Solutions, LLC,
Betsy Hughes-Formella, PhD
Wilmington, NC, USA
bioskin GmbH, Hamburg, Germany May 27 - 28, 2010
Segundo Mariz, MD
Ulrike Ebert, MD Medical Assessor, MHRA, London, England HAMBURG, GERMANY
Intendis GmbH, Berlin, Germany
PROGRAM
Phase I and QoL
In this workshop many of the key issues and challenges Preclinical requirements and FDA strategy
14:00 lrritation and sensitization testing from a
involved in the successful development of dermatologi-
cals will be addressed. Practical guidance will be given dermatologist’s perspective 11:00 Preclinical requirements for clinical trials of
as well as discussion of strategies and regulatory re- Walter Wigger-Alberti, bioskin GmbH, dermatological products -
quirements. Time for questions and discussion will Hamburg, Germany a regulator's view
encourage interaction among participants and experts. Elke Röhrdanz, BfArM, Bonn, Germany
14:45 Quality of life assessments in dermatology
Professor Andrew Finlay, Cardiff, UK 11:45 Tips for successful FDA negotiations and hot
topics for development of dermatological
Day 1 Thursday May 27 15:30 Coffee break
products in the US
Innovation and methodology Michelle Carpenter, Dow Pharmaceutical
9:00 Welcome and introduction
Sciences, Inc., Petaluma, CA, USA
Betsy Hughes-Formella, bioskin GmbH, 16:00 A review of imaging techniques and analysis
Hamburg, Germany methodologies for the clinical research pursuit 12:30 Lunch
Speaker from Canfield Scientific
Formulation and In-Vitro Penetration Regulatory requirements
16:45 DermAxess®: Access to continuous in-vivo
9:10 Science and art of dermatological formulations: 13:45 Clinical requirements for approval of topical
sampling in skin for realistic probes
Pathway to success drugs from regulator’s view
Frank Sinner, Joanneum Research,
Speaker from Dow Pharmaceutical Sciences, Regulatory speakers from several European
Graz, Austria
Inc., Petaluma, CA, USA agencies including Segundo Mariz from the
17:30 End of presentations day 1 MHRA
9:55 Effective use of in vitro skin penetration
studies in topical formulation development 19:00 Dinner 15:15 Coffee break
Daniel Bucks, Dow Pharmaceutical Sciences,
16:00 Regulatory round table with all speakers from
Inc., Petaluma, CA, USA
day 2
10:40 Coffee break Day 2 Friday May 28 17:15 End of the workshop
Preclinical and translational dermatology Pediatric development and generics
11:10 Nonclinical and dermatology: What is special 9:00 EU & US regulatory requirements for pediatric
for development of topicals development: Update 2010 & the specific
Sandra Johanssen, Intendis GmbH, Berlin, challenges of dermatological products
Germany Klaus Rose, Granzer Regulatory Consulting
11:55 Translational medicine in dermatology and Services, Munich, Germany
TBD 9:45 The vasoconstriction assay for BE of topical
12:40 Lunch corticosteroids: A retrospective look 5 years
after introduction of the US FDA guidance.
Charles Bon, Biostudy Solutions, LLC,
Wilmington NC, USA
10:30 Coffee break
