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Regulatory Affairs for Biologics

Oct 19 2014 8:30AM - Oct 20 2014 3:15PM | University of Southern California 2300 Michelson Dr, Irvine, CA 92612-1308 USA

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Overview 

Participants in this training course will learn the differences between traditional biologics and biotechnology products, the regulatory needs and requirements for biologics, the unique aspects in the development of specific biologics such as vaccines and cellular therapy, and the different ways that CBER and CDER view product development. The course will also discuss proven strategies to achieve regulatory success in the development of biologics.

Course Level: Intermediate

What You Will Learn 

  • Difference between traditional biologics and biotechnology products
  • Regulatory needs and requirements for biologics
  • Unique aspects in the development of specific biologics such as vaccines and cellular therapies
  • Differences in how CBER and CDER view product development
  • Establishing effective working relationships with CBER and CDER review offices.

Who Should Attend 

Professionals involved in:

  • Regulatory affairs
  • Government and academia
  • Quality assurance and manufacturing
  • Project management

Learning Objectives 

At the conclusion of this activity, participants should be able to:

  • Discuss product jurisdiction and how it affects the review of biologic products
  • Identify the unique aspects of biologics and how their development compares to that of small molecules
  • Describe the strategy differences for successful interactions with FDA CDER and CBER review offices
  • Discuss the regulatory mechanisms available to speed biologics development
  • Explain current regulatory, global, and public opinion trends that impact biologics

Special Offers 

Group Discounts Available! Register 3 and Get the 4th FREE!

Hotel & Travel 

Training Course Location
University of Southern California
Orange County Center, 2300 Michelson Drive
Irvine, CA 92612 USA

Hotel Information
Attendees must make their own hotel reservations, but only after receiving written confirmation from DIA.

Suggested nearby hotels:
Ayres Hotel & Suites
325 Bristol Street, Costa Mesa, CA 92626
Phone: +1-714-549-0300 or +1-800-454-1692
Click Here and  Ask for the USC rate.

Wyndham Irvine-Orange County Airport
17941 Von Karman Avenue, Irvine, CA 92614
Phone: +1-949-863-1999
Website: Click Here

Marriott Hotel Irvine
18000 Von Karman Avenue, Irvine, CA
Phone: +1-949-553-0100
Website: Click Here 

Contact Information 

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Agenda and Event Logistics
Susan Berkelbach, Event Planner
Phone +1.215.442.6183
Fax +1.215.442.6199
Susan.Berkelbach@diahome.org

Faculty 

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Continuing Education 

Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer 1.3 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

This program is part of DIA’s Certificate Program and is awarded the following:
• Regulatory Affairs Certificate Program: 8 Core Units

For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Regulatory Affairs for Biologics IACET 12.50 1.300

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

If you would like to receive a statement of credit, you must attend the activity, sign-in at the DIA registration desk each day of the activity, and complete the online credit request process through My Transcript at www.diahome.org . Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests two weeks after the last day of the activity.
Please note: If you do not sign-in, you will not receive CE credit as partial credit will not be awarded.

To view DIA’s Grievance Policy, please visit the CE page on the DIA website at www.diahome.org/CE

Registration Fees 

Member

Charitable Nonprofit/Academia Member
$810.00
Member Government
$810.00
Member Standard
$1375.00
Member Standard (As of 09/29/2014)
$1475.00

Non-Member

Charitable Nonprofit/Academia Nonmember
$1035.00
NonMember Government
$1035.00
NonMember Standard
$1700.00
Group Discounts

Printable Registration Form

Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred. Group registration is not available online and does not apply to the already discounted fees for government or charitable nonprofit/academia.

To take advantage of this offer, please make a copy of this registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.

Register Online

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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