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Patheon Invites you to a Complimentary Seminar

With tight budgets and even tighter deadlines, the intense demands of clinical trials can draw focus away from the ultimate goal. This half-day intensive seminar features the insights of highly experienced scientists from across the pharmaceutical development/commercialization lifecycle. In one afternoon, they’ll demonstrate how robust, reliable and repeatable processes pay dividends today and tomorrow.

Seating is limited. Register as soon as possible.

 

Information

Date: 24 September 2013
Time: 12-5:30pm
Location: Patheon, 40 Boulevard de Champaret, 38300 Bourgoin-Jallieu, France
RSVP: Register now or email events@patheon.com
Cost: Free
If you are unable to attend, or think that this seminar would be of interest to a colleague, please feel free to pass along this invite.
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Learn How to Build Reliable Quality and Manufacturability into Your Product

The drive toward late development requires a significant increase in financial commitment. This makes it all the more important that the moment you receive regulatory approval, everything is in place for a rapid and efficient move into production. What you do at this critical stage will determine your success later.

This half-day seminar will cut straight to the bedrock science underlying the development of a process that is robust, reliable and repeatable. Core topics will include:

QbD – Establishing expectations, issues and challenges
Scale-Up – Building a robust process suited for every stage
Technology Transfer – How to move with efficiency across a facility or around the world
Regulatory Compliance – Informed planning to avoid costly, unnecessary delays

Our experts will answer your questions through interactive Q&A sessions after each presentation. There will also be opportunities for scientific discussions during the networking lunch at the start of the proceedings. In addition, Patheon would like to offer the opportunity to tour our modern facilities at Bourgoin and to join the Patheon team at a networking reception.

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Agenda
Time Activity
12:00 – 12:30PM Registration and Lunch
12:30 – 12:40PM

Opening Remarks

12:40 – 1:20PM

QbD at a Contract Development Organisation
Francois Berthier, Patheon France

1:20 – 2:00PM

Experiences of Scale-Up – The Good, the Bad and the Ugly
Mike Dey, Claidmhor Pharma Limited

2:00 – 2:30PM Networking Break
2:30 – 3:10PM

A Global Approach to Technology Transfer
Romano Rivolta, Patheon France

3:10 – 3:50PM

Regulatory Compliance: A Win-Win Approach
Katherine Griotier, Patheon Inc.

3:50 – 4:00PM Closing Remarks
4:00 – 5:30PM Facility Tours and Networking Reception
Please join our forum and either post a question or join in the pre-event discussions:
Join Patheon Scientific Forum in LinkedIn
 
About the Speakers

Mike Dey, Ph.D. has over 30 years of experience building commercial success into products. He has gained approvals, scaled-up and launched over 20 drug products, including several that achieve over $1 Billion annual sales. ...read more

Francois Berthier is Director, Process Technology and Pharmaceutics, at Patheon France Bourgoin Jallieu Development unit (PDS). He has 21 years of experience in pharmaceutical process technology, 13 of which are at Patheon. ...read more

 

Katherine Griotier, Ph.D. is Senior Director, European Industrial Regulatory Affairs based in Patheon France (Bourgoin-Jallieu site).  Katherine has 24 years experience in pharmaceutical regulatory affairs, 13 of which are at Patheon. ...read more

Romano Rivolta is Senior Director, Business Management and Technology Transfer at the Patheon France Bourgoin-Jallieu site. Mr. Rivolta’s extensive experience in contract manufacturing and development operations serving as Director for NextPharma and Cenexi leading development, ...read more

Patheon, your host company, is a leading global provider of contract pharmaceutical development and manufacturing services with an integrated network of eight development centers of excellence and thirteen manufacturing facilities across North America and Europe. Patheon provides pharmaceutical and biotechnology companies with direct access to the expertise, quality and full range of solid and sterile dosage forms to bring drug candidates from preclinical stages through production, and launch products anywhere in the world. In 2008, 2010 and 2012, The European Outsourcing Awards recognized Patheon for executing the most effective scale-up and technology transfers.

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