[Plsfaculty] FW: "How to Navigate the Biotech Regulatory Process" A Works hop and Networking Reception

[Donna-Rae Marquez]

From: Printing & Publishing 3Ds [mailto:PPSS3DS at LISTSERV.ARIZONA.EDU] On
Behalf Of 3D Memo
Sent: Friday, September 16, 2011 3:37 PM
To: PPSS3DS at LISTSERV.ARIZONA.EDU
Subject: "How to Navigate the Biotech Regulatory Process" A Works hop and
Networking Reception

 

TO: The UA Research Community

 

FROM: Bruce Wright, Associate Vice President for University Research Parks

 

SUBJECT: "How to Navigate the Biotech Regulatory Process" A Workshop and
Networking Reception

 

Presented by the Office of University Research Parks and The Arizona Center
for Innovation  

 

When: Tuesday, September 20, 2011

            Workshop:  8:00 am - 4:15 pm

            BIO-SA Reception: 4:30 - 6:00 pm

 

Where: Doubletree Reid Park

445 S. Alvernon Way, Tucson, AZ 85711 

 

Cost: $25 (includes materials, lunch and reception)

 

Workshops Include:

 

-       General overview of the FDA regulatory process

-       Importance of your patient demographic market

-       Learn how to best develop and implement an international strategy
for selling your device or drug outside the US

-       Explore future trends in the development of new drugs and devices as
well as the regulatory process

 

Presenters: 

 

Marlene Haffner, MD, MPH is the CEO of Haffner Associates, LLC., a firm
dedicated to the strategy, development and policy of drug development with a
special emphasis on rare diseases and the products that treat them.  She
also spent more than 25 years working for the FDA as the Director of the
Office of Health Affairs in the CDRH, and Director of the Office of Orphan
Products Development

 

David Feigal, MD, MPH is a Partner NDA Partners.  He held senior positions
in FDA medical product centers including the Center Director of CDRH, the
Deputy Center Director of CBER and Director of the Office of Drug Evaluation
IV (Anti-infective-Antiviral Drug Products), CDER.

 

Barbara Wuebbels, RN, MS -is the Manager of Medical Affairs Investigator
Relations for BioMarin Pharmaceutical located in Novato, CA.  She has worked
in the orphan drug arena for the past 12 years.  Prior to joining BioMarin,
she was Director at Ucycld Pharma a subsidiary of Medicis Pharmaceutical
Corp.  She is actively involved with national and international rare disease
organizations and patient advocacy groups.

 

For more information:

 
<http://azinnovation.com/sites/default/files/FDA%20Workshop%20Flyer%20Final.
pdf>
http://azinnovation.com/sites/default/files/FDA%20Workshop%20Flyer%20Final.p
df

 

To register please contact Lori Kavanaugh at 520.382.3260 or
lkavanaugh at azinnovation.com

 

-------------- next part --------------
An HTML attachment was scrubbed...
URL: <https://list.cals.arizona.edu/pipermail/plsfaculty/attachments/20110916/f263f7b8/attachment.htm>