Regulatory Affairs for Biologics
Mar 11 2013 8:30AM - Mar 12 2013 2:30PM | DIA
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509
USA
Overview
Discuss proven strategies to achieve regulatory compliance for 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 February 24, 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
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.
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 DIA’s website at www.diahome.org
Registration Fees
Member
- Charitable Nonprofit/Academia Member
- $810.00
- Member Government
- $810.00
- Member Standard
- $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
Cancellations: Cancellations must be received two weeks prior to the first day of the course. A $200 administrative charge will be deducted from the original registration fee. Cancellations must be in writing and received in the DIA office according to the timeline above. There will be no refund if cancellation is received within two weeks from the first day of the course. Registrants are responsible for cancelling their own hotel and travel reservations. Registrants who do not cancel prior to the course and do not attend will be responsible for the full registration fee. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for airfare, hotel or other costs incurred by registrants.
Transfers: You may transfer your registration to a colleague at any time but membership is not transferable. Please notify the DIA North American office of such transfers in writing as soon as possible. Substitute registrants will be responsible for the nonmember fee, if applicable.
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.
Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.