Regulatory Information Management 2014
Feb 25 2014 8:25AM - Feb 26 2014 4:00PM | Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road,
North Bethesda, MD 20852
With an increased focus on getting innovative therapies to market, ensuring patient safety and regulatory compliance with approved application information, organizations are challenged to operate with a global perspective. The ability to access and use information in the data-rich world of the BioPharma and Medical device industries is critical to success. Effective regulatory information management (RIM) processes and tools are needed to ensure organizations are effectively and efficiently developing new products and conducting life-cycle management while also remaining compliant with approved product registrations. This two-day annual conference will share strategies on interpreting the regulatory requirements for filing, best practices for managing information, and review of many new or changing regulatory requirements.
The DIA Regulatory Affairs Community and an expert program committee are developing this conference, which will feature plenary sessions on latest trends in the industry.
Sessions are separated into two tracks:
- The Business Track will provide the opportunity to interact and share experiences related to processes for obtaining and managing regulatory information and the organizational impact as well as gain a greater understanding of key issues shaping the global regulatory environment.
- The Technology Track will focus on standards related to submission of regulatory information, the tools necessary to effectively manage the information, and associated implementation experiences and lessons learned.
The conference will include a Vendor Showcase.
Who Should Attend
- Clinical Research & Development/Clinical Supplies
- Global Project Managers
- Information Technology
- Regulatory Affairs/Operations
- Regulatory Information Management
- Regulatory, Medical, and Technical Writers
At the conclusion of this conference, participants should be able to:
- Identify key business drivers for establishing a global regulatory information management system
- Share industry best practices related to standards and processes needed for effective regulatory information management
- Recognize the important role of regulatory intelligence in a regulatory information management strategy
- Gain understanding of critical changes in the global regulatory environment
Group Discounts Available! Register 3 and Get the 4th FREE!
Hotel & Travel
Bethesda North Marriott Hotel & Conference Center
A limited number of rooms are available at the reduced rate shown below (rate is guaranteed until February 7, 2014, or until room block is filled). Please note: In order to receive the reduced room rate, hotel reservations must be made with Travel Planners and not directly with the hotel. Contact information for Travel Planners is as follows: Attendees can follow this link or call+1.212.532.1660 or 1.800.221.3531 in the U.S. When calling please select option 1 for “Hotel Reservations,” and inform the phone agent that you are making a reservation for Event #14005.
Standard Room Rate $159
Hotel Address: 5701 Marinelli Road North Bethesda, MD 20852
The most convenient airport is Washington Dulles International Airport – IAD or Ronald Reagan Washington National Airport - DCA and attendees should make both airline and hotel reservations as early as possible.
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; +1.703.506.3275.
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.
DIA’s Certificate Program
This program is part of DIA’s Certificate Program and is awarded the following:
• Regulatory Affairs Certificate Program: 8 Elective Units
For more information go to www.diahome.org/certificateprograms
|Regulatory Information Management 2014
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 program, sign in at the DIA registration desk each day of the program, and complete the on-line credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. 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 on Wednesday, March 12, 2014.
To view DIA’s Grievance Policy, please visit the CE page on DIA’s website at www.diahome.org/CE
The Regulatory Information Management 2014 Conference offers interested companies the opportunity to exhibit with a tabletop display.
Tabletop registration for this conference is now CLOSED - space has SOLD OUT.
Tabletop Fee: $1,500
- One six-foot skirted table
- One chair
- Standard electricity
Each tabletop rental requires at least one registered attendee to staff the table. All tabletop staff must be registered conference attendees.
Tabletop Exhibit Dates
February 25-26, 2013
- Accenture Life Sciences
- Computer Science Corporation
- INFOTEHNA Inc.
- Lorenz International LLC
- Mission3, Inc.
- Charitable Nonprofit/Academia Member
- Member Government
- Member Standard
- Charitable Nonprofit/Academia Nonmember
- NonMember Government
- NonMember Standard
Printable Registration Form
Register three individuals from the same company and receive complimentary registration for a fourth! All four individuals must register and prepay at the same time – no exceptions.
To take advantage of this offer, please make a copy of the registration form for EACH of the four registrants and include the names of all other group registrants in the Group Discount section. 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.
CANCELLATION POLICY: All cancellations must be received in writing two weeks before
the start of the event. Administrative fee that will be withheld from refund amount:
- Member or Nonmember = $200
- Government or Academia or Nonprofit (Member or Nonmember) = $100
- Tutorial (if applicable) = $50
Cancellations must be in writing and be received two weeks before the start of the event. Registrants who do not cancel two weeks before the start of the event and do not attend the event will be responsible for the full registration fee. Registrants are responsible for cancelling their own hotel and airline reservations. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.
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.