Document Sample
Early registration until April 30
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,
1000 € for Non-Member
                                                        Sandra Johannsen, DVM, PhD, ERT
700 € for AGAH Member
                                                        Global Preclinical Development, Intendis GmbH, Berlin,
                                                        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:                                    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
                                                           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

Shared By: