Groundbreaking Workshop on

Assuring Quality and Performance
of Sustained and Controlled Release Parenterals

February 17-18 • 2003 • Basel Convention Center • Switzerland

	Download the Second Announcement
	Download the Conference Registration Form
	Download the Hotel Registration Form

Scope and aim
In April, last year, the American Association of Pharmaceutical Scientists (AAPS), the Food and Drug Administration (FDA) and the United States Pharmacopoeia (USP) co-sponsored a workshop on Assuring Quality and Performance of Sustained and Controlled Release Parenterals. This very successful workshop brought together scientists from industry, academia and the regulatory authorities to review, discuss and debate formulation, processing and manufacture of sustained and controlled release parenterals and to identify critical process parameters and their control. Areas were identified where research is needed in order to understand the performance of these drug delivery systems and to assist in the development of appropriate testing procedures. Recommendations were made for future workshops, meetings and working groups in this area. A full Workshop Report is available in the AAPS on-line journal AAPSPharmSci which can be accessed via the AAPS web portal AAPSPharmaceutica.

This (European) Workshop follows on from the US Workshop and will specifically bring the European Regulatory viewpoint as well as focus on some of the areas identified in the US workshop that required further debate and discussion (such as, particle size analysis, stability, sterility and new excipients). It will cover dispersed systems (micro-spheres, liposomes, gels and suspensions) as well as implants of small molecule and protein/peptide therapeutics for human and animal use. It will be a unique and intensive discussion forum with plenary lectures, breakout sessions, and a final report, bringing together industrialists, academics, and regulatory scientists to identify future directions for regulatory activity and public standards in this rapidly emerging area.

Goals and objectives include:

• To review formulation, processing and manufacture of CR parenterals.
• To identify and discuss critical process parameters and their control.
• To identify new, emerging methods of in vitro release testing for CR parenterals and their ability to predict product performance.
• To discuss accelerated stability and in vitro release testing methods for CR parenterals.
• To discuss bioavailability, bioequivalence and pharmaceutical equiva-
  lence for CR parenterals.
• To explore the opportunity for in vitro- in vivo correlation of CR parenterals.
• To provide input for a Workshop Report for future directions for regulatory activity and public standards in this area.

• CMC issues (formulation, processing, manufacture, sterilization and stability)
• Specifications/characterization (e.g. particle size, percent drug loading,
  stability testing and release, analytical issues)
• Development of in vitro release standards
• In vivo testing and use of animal models
• In vitro-in vivo correlation opportunity

• Editorial Instructions

• Opening of the Workshop
  Dominique Duchêne, EUFEPS President, Paris FR
• Genesis of this Workshop and report from the 2001
  AAPS/FDA/USP Workshop
  Diane J. Burgess, Storrs CT USA

Session I: Review of Formulation, Development and Manufacture of Different Products
Chairman: Daan J.A. Crommelin, Utrecht NL

• Liposomes
  Frank Martin, Mountain View, CA USA
• Microspheres
  Jean-Pierre Benoit, Angers FR
• Gels
  Thomas Kissel, Marburg DE
• Suspensions
  Lotte Langkjaer, Bagsvaerd DK
• Implants
  Paul Gellert, Macclesfield UK

Session II: Assuring Quality and Performance of CR Parenterals - CMC Issues (A product with a long duration of actions, and a “fragile” product from each of the two classes, will be used as examples)
Moderator: Diane J. Burgess, Storrs CT USA

• Implants: EMEA/FDA Perspective
  Philippe Maincent, Nancy FR
• Liposomes: EMEA/FDA Perspective
  Art Shaw, Rockville MD USA
• Implants
  Simon Hartas, Macclesfield UK
• Liposomes: Industry Perspective
  Frank Martin, Mountain View, CA USA

Monday Breakout Sessions on CMC Issues (Round 1)

Monday Breakout Sessions on CMC Issues (Round 2)

Exhibitor Introductions

Dinner Reception

Tuesday, February 18, 2003

Session III: Assuring Quality and Performance of CR Parenterals - (Bio)pharmaceutics and Analytical Issues
Moderators: Mei-Ling Chen, Rockville MD USA; Rainer Müller,
Berlin DE

• Overview of physiology of different parenteral routes of administration using animal models
  Paul Dickinson, Macclesfield UK
• Regulatory considerations for bioavailability and bioequivalence of CR parenterals products
  Mei-Ling Chen, Rockville MD USA
• In vitro release testing: Overview of current EP/USP methods and need for new methods for CR parenterals
  Diane J. Burgess, Storrs, CT USA
• Overview of in vitro/in vivo correlation
  David Young, Hanover MD USA
• In vitro release testing as a regulatory tool: Microspheres
  Diane J. Burgess, Storrs CT USA
  Implants
  Brian Clark, Macclesfield UK
  Suspensions
  Rainer Müller, Berlin DE
  Liposomes
  Frank Martin, Mountain View, CA USA

Tuesday Breakout Sessions
(Divided into in vitro release and (bio)pharmaceutics issues)

Session IV: Summary of Breakout Sessions and Wrap-Up
Moderators: Diane J. Burgess, Storrs CT USA; Daan J.A. Crommelin, Utrecht NL

Registration and Payment
Please complete the Registration Form and return it to the EUFEPS Secretariat. The registration fee includes all workshop documentation, all coffee breaks, two lunches and one dinner buffet. The cost for hotel accommodation and travel is not included in the registration fee.

Registration Fees

Hotel Reservation
A number of hotel rooms have been reserved at specially reduced rates. For hotel categories and rates (including VAT), see the Hotel Reservation Form. Complete the Hotel Reservation Form and send it to the Basel Hotelreservation, Postfach, CH-4021 Basel, Switzerland, fax: +41 61 6862184, no later than January 31, 2003.

Cancellations
Pre-registered delegates who are unable to attend the Conference will be refunded, except for an administrative fee of EUR 40, provided the Conference Secretariat receives a written notice of non-attendance, before January 18, 2003. No refunds can be made for cancellations received after this date. Substitutions may, however, be made at any time. The name of the substitute/s should be forwarded to the EUFEPS Secretariat.
For cancellations etc. of hotel reservations, please contact the Basel Hotelreservation to establish what terms apply.

EUFEPS Secretariat Attn: Annika Nyman PO Box 1136 SE-111 81 Stockholm Sweden Phone +46 8 7235000 Fax +46 8 4113217 Email conferences@eufeps.org	Conference Venue Basel Convention Center Messeplatz 21 Postfach CH-4021 Basel Switzerland Phone +41 61 6862828 Fax +41 61 6862185
Hotel Reservation Basel Hotelreservation Postfach, CH-4021 Basel Switzerland Fax +41 61 6862184