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Regulatory Affairs for Biologics

Sep 23 2013 8:30AM - Sep 24 2013 2:30PM | DIA 800 Enterprise Rd Ste 200, Horsham, PA 19044-3509 USA

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Overview 

Unlike traditional small molecule drug development, the development of biologics products presents unique challenges for the regulatory professional. In the absence of clear guidance on new products and therapeutic approaches, regulatory strategy becomes key to a time and cost efficient road to approval. This course will discuss proven strategies to achieve regulatory success in the development of biologics.

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 gene therapy
  • Differences in how CBER views product development compared to CDER

Who Should Attend 

Professionals involved in:

  • Regulatory affairs
  • Quality assurance
  • Project management

Learning Objectives 

At the conclusion of this activity, participancts 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 unique CMC compliance reporting aspects of biologics
  • Discuss the regulatory mechanisms available to speed biologics development
  • Explain the current regulatory, global, and public opinion trends that have the potential to impact biologics

Special Offers 

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

Hotel & Travel 

Training Course Location
DIA Worldwide Headquarters
800 Enterprise Road, Suite 101
Horsham, PA 19044

Hotel Information
Homewood Suites
2650 Kelly Road
Warrington, PA 18976
Phone +1-215-343-1300
Fax +215-343-1335

A limited number of rooms are available at the reduced rate shown below (DIA is guaranteed until September 8, 2013, or until room block is filled). Attendees should make airline and room reservations as soon as possible.
When making reservations, mention the DIA training course.
Standard Room Rate
$119
Click here for more hotel information

Contact Information 

Registration Questions
Vicki Adkinson, Customer Service Associate
Phone +1.215.442.6162
Fax +1-215.442.6199
Vicki.Adkinson@diahome.org

Agenda and Event Details
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), 1760 Old Meadow Road, Suite 500, McLean, VA 22102 (703) 506-3275.

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 1.2 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 11.75 1.200

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 09/03/2013)
$1475.00

Non-Member

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

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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