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CMC Strategy Forum Europe 2008

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CMC Strategy Forum Europe 2008

Apr 08 - 09, 2008

HOTEL

Paris Marriott Rive Gauche Hotel & Conference Center Hotel Surroundings

Located on the left bank, in the 14th Arrondisement, the hotel is situated next to the Latin Quarter and is close to the Eiffel Tower, the Orsay Museum, the Luxembourg Gardens, the Pantheon, restaurants and shopping.

17, Boulevard Saint-Jacques
75014 Paris, France
Phone: 33 1 4078 7980
Fax: 33 1 4588 4393
Please visit the hotel's web site for more information and to book reservations online with the Group code GDEGDEA
www.marriott.com/parst

Please book well before the hotel deadline of 7 March 2007 for the group rate Euro 225 including full breakfast and VAT.

Airport Bus, Train/Metro and Taxi

Nearest Airports:
Paris Orly Airport (ORY): Approximate driving time to Paris Rive Gauche Hotel is 25 minutes anddistance is 14 kilometres (8.5 miles). Hotel Direction: 14 NE - Driving Directions: Follow PARIS SUD signs to the Porte d'Orleans. Take the Avenue General Leclerc to Denfert Rochereau square. Turn right on Boulevard St Jacques. The hotel is situated on number 17, the doorman will indicate you the way to our parking.

Bus service fee: 6.1 EUR (one way), From 5:30 AM - 11:30 PM you can take the Orly Bus, (buy a ticket from the bus driver or at the kiosk by the bus stop and validate on board), in the direction Denfert-Rochereau (about 20 minutes) which is the last stop. You get off in front of the Denfert-Rochereau train station and walk to the right, down the boulevard Saint Jacques (about 7 minutes). You may also take the METRO from Denfert-Rochereau (line 6 - direction Nation), just two stops to Glaciere, the hotel is between the St. Jacques and Glaciere Metro stops.
Estimated taxi fare: 30.0 EUR (one way)

Paris Charles de Gaulle Airport (CDG): Approximate driving time to Paris Rive Gauche Hotel is 50 minutes and distance is 45 kilometers (28 miles). Hotel Direction: 45 S - Driving Directions: Follow PARIS EST signs to the Porte d'Orleans. Take the Avenue du Général Leclerc to Denfert Rochereau square. Turn right on Boulevard Saint Jacques. The hotel is situated on number 17, the doorman will indicate you the way to our parking.

Bus service, fee: 11.5 EUR (one way)
Subway service fee: 8.2 EUR (one way) From the Get the Regional Express Train (RER line B - direction Robinson - St Remy Les Chevreuses) until Denfert-Rochereau. It will take about 45 minutes, at Denfert-Rochereau train station, take the Metro (line 6 - direction Nation) just two stops until Glaciere station or walk down the boulevard Saint Jacques (about 7 minutes), the hotel will be on the right.
Estimated taxi fare: 50.0 EUR (one way)

FROM GARE DU NORD STATION (EUROSTAR / THALYS)

Get the Regional Express Train (RER line B - direction Robinson - St Remy Les Chevreuses) until Denfert-Rochereau. It will take bout 10 minutes, and approximately cost 1.40 euros. At Denfert-Rochereau station, when exiting, walk to the right of the exit, down the boulevard Saint Jacques (about 7 minutes), the hotel will be on the right. It is very convenient to the Denfert-Rochereau train station.

Parking

On-site parking, fee: 20 EUR hourly, 20 EUR daily
Valet parking, fee: 20 EUR daily
Off-site parking; contact hotel for details

We are pleased to introduce the 2nd CMC Strategy Forum Europe, organized by CASSS and co-sponsored by the United States Food and Drug Administration (FDA). The objective of the Forum is to provide an environment for the development of technical and regulatory consensus positions regarding the topics of the meeting which will be communicated to regulatory agencies and Industry through appropriate mechanisms (e.g., publications).

The mission of the Forum is to:

Provide a biotechnology/biological product forum that focuses on relevant CMC issues throughout the global product development cycle
Foster collaborative technical and regulatory interactions
Share information with the regulatory agencies to assist them in merging good scientific and regulatory practices

The Forum will also provide a venue for discussing the latest bio-molecular methods and their practical application to biotechnology pharmaceuticals and other health related products. This includes both method and instrumental advances that are used for product characterization, process development, and validated in-process, release and stability tests.

Workshop Format

Each meeting will focus on CMC related issues such as product characterization, comparability, specifications, etc. the format of each meeting will consist of case studies and presentations by regulatory agencies and industry experts to introduce the topic and the key issues of concern. Attendee participation is crucial to the successful development of consensus positions. Prior to the meeting, registrants may be contacted to solicit in put on key issues of concern. It is envisioned that the final outcome of the workshop discussions will be the development of a document to be submitted to the appropriate regulatory agencies for their consideration in developing and/or clarifying good regulatory practice guidelines for biotechnology derived products.