PDA Southeast Chapter
Fall Conference, Vendor Show & Networking Social

Three Events - One Day!

 Wednesday, October 24, 2012

Hilton North Raleigh / Midtown
3415 Wake Forest Road
Raleigh NC, 27609

ONLINE REGISTRATION IS LOCATED BELOW AGENDA

Questions? Contact Debora Steenson at PDASE@bluestarservices.net

Earlybird Rate Ends October 11, 2012

Register by October 11, 2012 to receive the earlybird rates
Member registration is $100/person
Non-member registration is $115/person
Student registration is $25/person

Registration after October 11, 2012
Member registration is $110/person
Non-member registration is $125/person
Student registration is $35/person

Exhibitors - One Company Representative Included
Exhibit Only Rate - Register by October 4, 2012  $495  after October 4, 2012  $595

Exhibit with Sponsorship- One Company Representative Included
Exhibit with Continental Breakfast Sponsorship Register by October 4, 2012 $645.00 after October 4, 2012 $745.00
Exhibit with Mid-morning Break Sponsorship Register by October 4, 2012 $645.00 after October 4, 2012 $745.00       
Exhibit with Lunch Sponsorship Register by October 4, 2012 $745.00 after October 4, 2012 $845.00
Exhibit with Afternoon Break Sponsorship Register by October 4, 2012 $645.00 after October 4, 2012 $745.00
Exhibit with Lunch Sponsorship Register by October 4, 2012 $745.00 after October 4, 2012 $845.00

Need hotel accommodations for Tuesday evening? Contact Hilton North Raleigh/Midtown at 919.872.2323. Request the PDA Southeast group rate of $119, single or double. Accommodations are available on a First Come, First Serve Basis. Rate ends September 23rd or when all rooms are filled, whichever occurs first.

Conference
"Regulatory & Compliance Initiatives for Global Harmonization"
8:00am - 5:00pm

With the world shrinking as fast as it is Pharmaceutical, Biotech, Medical Device, and API companies are facing significantly more challenges in meeting the expectations of regulatory agencies for different countries.  The US, Europe and Japan used to be the primary source for compliance regulations, but that is changing rapidly with growing scientific and technical knowledge and patient needs around the world.  Several international cooperative organizations have been formed in response to the increasingly global face of drug development, manufacturing and distribution - the World Health Organization (WHO), the International Conference on Harmonization (ICH), the Pharmaceutical Co-operation Inspection Scheme (PICs) and Rx360-An international Pharmaceutical Supply Chain Consortium to name just a few.  The ultimate goal of these international cross-functional groups is to ensure that safe, effective, and high quality medicines are available so that better health can be realized worldwide.

Topics Include
Harmonized Submission Document Strategies
Regulations vs. Guidelines: Similarities and Differences
Pursuing Global Transparency in the Raw Material Supply Chain
Worldwide Consistency in Steam Sterilization Regulations
International Packaging & Distribution Practices
Inspection Trends: a Global Perspective

Other topics under consideration
Drug Shortage Impact to International Markets
Compliance Strategies for Global Markets
Domestic vs. International Inspection Observations
Current & Future FDA Initiatives for International Compliance
Harmonization of GMP through PIC/S

 Vendor Show
Exhibit Hall Opens at 7:30am!
7:30am - 7:30pm 

Here's your chance to talk with vendors, consultants and suppliers - all in one place.  Looking for new laboratory equipment & supplies?  What about innovative manufacturing technologies? Or do you need professional validation services?  Be sure to visit the Exhibit Hall during breakfast, break and lunch times and speak to the on-site representatives. 

Networking Social
"Life Saving Therapies - A Patient's Perspective"
5:00pm - 7:30pm 

Join us in the Exhibit Hall after the Conference for this exciting Social Networking event featuring a special guest speaker.