October 17th, 2014

Outsourcing 101


You are Invited to the Joint Fall Conference 


Sponsored by

San Diego Regulatory Affairs Network (SDRAN)


Orange County Regulatory Affairs Discussion Group (OCRA) 


Wednesday, November 19, 2014 


Location:  Grand Pacific Palisades Resort & Hotel

5805 Armada Drive, Carlsbad, CA  92008



Program Managers:

Amelia Cline, RAC, Regulatory Affairs Specialist, Peregrine Pharmaceuticals

Mugdha Dongre, Regulatory Affairs Specialist, Bausch and Lomb

Sybille Sauter, PhD, Associate Director, Halozyme Therapeutics, Inc.



As more and more companies abandon the concept of creating products solely using their own internal resources, effective outsourcing has become a key success factor in drug and device development. Driven by an increasingly competitive commercial environment, products need to be produced faster, cheaper, and must be available to a global market. While cost reduction is still the primary goal behind most outsourcing, improved quality and a shorter time-to-market are two additional benefits of partnering with specialized vendors. The relationship between the client company and these vendors creates new opportunities and challenges. The question: How can you best establish and nurture this relationship?


The OCRA-SDRAN “Outsourcing 101” conference offers insight into current outsourcing trends and shares advice on vendor selection and vendor management. Industry experts will address topics such as choosing the right partner, relationship governance, legal aspects, and ensuring the quality of products globally. Additional two parallel panel sessions will focus on Pharmaceuticals/Biologics and Devices/IVD. During these roundtables with vendor representatives, you will have the opportunity to pose questions to the panel and receive helpful suggestions from some of the most experienced professionals in the business. Make sure you don’t miss this opportunity to join your colleagues in beautiful Carlsbad, CA at the Grand Pacific Palisades, share your own expertise, and learn from some of the best in our field.



7:30 – 8:15Registration and Continental Breakfast8:15 – 8:30Opening Remarks: Regina O’Meara, OCRA President and IVD Regulatory Consultant8:30 – 9:00Keynote Speaker: tbd9:00 – 9:45

Topic: Legal aspects of outsourcing

Speaker: Michael Swit, Special Council, FDA Law Practice, Duane Morris LLP

9:45 – 10:00BREAK10:00 – 10:50

Topic: Outsourcing for IVDs and Devices

Speaker: Natalie Kennel, President, NJK & Associates

11:00 – 11:50

Topic: Choosing the right toxicology CRO for your program

Speaker: Grace Furman, President/CEO, Paracelsus, Inc.

12:00 – 1:00Lunch1:00 – 1:30

Topic: Clinical trial conduct with CRO support

Speaker: tbd

1:35 – 2:05

Topic: Study data collection & verification

Speaker: Jamie Colgin, President, Colgin Consulting, Inc.

2:05 – 2:20

Introduction of panel sessions and chairs

Speaker: Regina O’Meara, OCRA President and IVD Regulatory Consultant

2:20 – 2:40BREAK2:40 – 4:10

Parallel Panel Sessions with Vendor Representatives: Discussion & Q&A

  • Drug/Biologics Panel (R. Lane, M. Paiz, chair: R. Hernandez)
  • IVD/Device Panel (A. Cotts, K. Kukulka, chair: N. Kennel)

4:15 – 4:30Closing Remarks: SDRAN President-elect


Additional speakers and panelists to be added to the agenda. Periodic updates will be sent as new speakers are added. 



OCRA and SDRAN Members: $199

Government and Students: $100


Registration fee includes parking, breakfast, lunch, beverages and snacks. After the meeting, electronic access to the presentations will be made for all attendees. Dress code: Business casual


 Click Here to Download the Event Flyer  



SDRAN Members:

Please register through SDRAN using this link:   http://www.sdran.org/


OCRA Members:

Step 1: 

Click on this link: http://www.ocra-dg.org/


Step 2:
Immediately log in with your username and password OR Create a new account by selecting “Register” on the top right hand side. If you are not an OCRA Member, it will ask you to join. Please keep in mind that to attend any OCRA meeting, we require you to become a Member. 


Step 3: 
Once you have logged on (and paid for membership) select the meeting you would like to attend and complete the registration process by filling in the appropriate fields.


If you are not a Member of either organization, we do require you to join either OCRA or SDRAN before registering for this meeting. 


To join OCRA go to this link:   http://www.ocra-dg.org/

To join SDRAN, go to this link:  http://www.sdran.org/


PAYMENT OPTIONS To Pay With Credit Card 

Register and pay online as described above.  If you prefer to fax your registration form, please click on the form below to download it.  Complete the form and fax it with your credit card payment to: 949-266-8461

Click here to download the registration form

To Pay With Company or Personal Check

Please register online (see instructions above). Then select the “Pay Off-Line” payment method and select “Company Check” or “Personal Check”. Make sure to mail your check at least 10 days prior to the conference to ensure it is receive in time. Only paid attendees will be able to attend. If a check has not been received, you will be asked to provide a credit card as a hold until the check is received.

Mail your check payable to: 

Orange County Regulatory Affairs Discussion Group 

5319 University Dr., Suite 641, Irvine, CA 92612 

Tel:      949-387-9046 

Fax:     949-266-8461 or 949-387-9047 

Email:  ksyre@cox.net 

OCRA’s non-profit Federal Tax ID# 33-0630455 

To Pay using PayPal

When registering online PayPal is one of the payment options.

PayPal requires that you set up an account with them prior to making payment for this meeting. Once you receive confirmation of your new account, then you can register for this meeting.

RECEIPTS FOR Outsourcing 101
Please use the online payment process for an immediate receipt.

Name badges and materials will be provided at the on-site registration desk.

Registration Fee includes the following: Electronic access to available presentations, continental breakfast, lunch and parking.

Sorry, no cancellations available for this meeting.



Grand Pacific Palisades Resort & Hotel

5805 Armada Dr, Carlsbad, CA 92008
Reservations (800) 725-4723

Front Desk (760) 827-3200


From San Diego:

Take I-5 North to Palomar Airport Road in Carlsbad and turn Right.

Turn Left on Armada Drive and then Left again into Grand Pacific Palisades Resort & Hotel.



From Orange County or Los Angeles:

Take I-5 South to Palomar Airport Road in Carlsbad and turn Left.

Turn Left on Armada Drive and then Left again into Grand Pacific Palisades Resort & Hotel.



Come and learn more about Outsourcing 101.