|
|
|
|
|
|
Find An Educational Offering
|
|
|
|
|
|
|
|
|
|
| |
 |
10027 Advancing Pediatric Research in the US
|
|
|
|
Title:
Advancing Pediatric Research in the US
Date(s) And Time(s):
Oct 12 2010 8:00AM - Oct 13 2010 5:00PM
Location:
DoubleTree Hotel and Executive Meeting Center
8120 Wisconsin Avenue
Bethesda, MD 20814
Interest Area(s):
Clinical Research,Clinical Safety/Pharmacovigilance,Outsourcing,Project Management,Regulatory Affairs,Research & Development
Overview:
Join Pediatric Research Experts to Share Solutions to the Challenges Involved in Constructing and Conducting Global Pediatric Programs.
Over the past three years industry has been busily climbing the steep learning curve of the EU Pediatric Legislation. With approved products and late stage development programs under compliance with the PIP, we have moved into a new era where early development projects are, for the first time, receiving input from the EU. How can the US FDA and industry dance with two partners and not step on anyone’s toes.
This workshop will review the global regulatory environment of pediatric research, share case studies for the successful implementation of clinical, nonclinical, and formulations development, and discuss the future of US pediatric research in the 2012 debate.
FEATURED TOPICS
• Regulatory Challenges in an Evolving Global Environment
This session will address how US and EU policies align (or not) to encourage pediatric research as we move forward.
• Global Pediatric Strategy: Real Issues and Successes - Industry, FDA and EMA Perspectives
This session will focus on what we have learned in these last three years and the challenges we continue to face.
• Implementation Challenges of Pediatric Research: From Early Considerations through Ethical Issues
This session will address recurrent challenges that pediatric study teams face in areas such as appropriate preclinical studies, child-friendly formulations, efficient methods in pharmacokinetic sampling, study designs in rare pediatric populations, and ethical considerations. We will look at these recurrent challenges and specific remedies utilized by study teams to overcome these challenges and deliver high quality, informative data.
• Lessons Learned on the Path Toward Better Medicines for Children
This session will look at what we have learned, particularly for the issues discussed in this workshop, and focus on what still needs to be solved to improve the path towards better medicines for children.
Co-located with Maternal and Pediatric Drug Safety Symposium – Special 3-day Pricing.
(Click here for program and pricing details)
Target Audience:
• Academic Health Centers/Investigator sites
• Business strategy
• Chemistry, Manufacturing and Controls/Good Manufacturing Practices
• Clinical research and development/Clinical supplies
• Clinical safety and pharmacovigilance
• Good clinical practices
• Nonclinical laboratory safety assessment
• Outsourcing
• Project management
• Regulatory affairs
• Statistics
Event Code:
10027
Contact Information:
EVENT INFORMATION
Contact Constance Burnett, Program Developer, Phone +1.215.293-5800
Fax +1.215.442.6199, email Constance.Burnett@diahome.org
Contact Joanne Wallace, Program Manager, Phone +1.215.442.6180
Fax +1.215.442.6199, email Joanne.Wallace@diahome.org
|
CME: This activity has been planned and implemented in accordance with the Essentials Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Postgraduate Institute for Medicine (PIM) and Drug Information Association (DIA). PIM is accredited by the ACCME to provide continuing medical education for physicians.
Postgraduate Institute for Medicine designates this educational activity for a maximum of 12.5 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
IACET: Drug Information Association has been approved as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 8405 Greensboro Drive, Suite 800, McLean, VA 22102; (703) 506-3275. Drug Information Association is authorized by IACET to off er 1.3 CEUs for this program.
| Advancing Pediatric Research in the US | CME
IACET
| 12.75
1.30
|
0.100
|
Disclosure Policy:
It is Drug Information Association policy that all faculty participating in continuing education activities must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosures 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, scan your name badge at the DIA registration desk each day of the program, and complete the on-line 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.
|
|
The most convenient airport is Ronald Reagan Washington National Airport and attendees should make airline reservations as early as possible. The DoubleTree Hotel and Executive Meeting Center is holding a block of rooms at the reduced rate below until September 20, 2010, for the DIA event attendees. Room availability at this rate is guaranteed only until this date or until the block is filled.
Single $169 Double $169
Attendees must make their own hotel reservations. Contact the DoubleTree Hotel and Executive Meeting Center by telephone at +1.240.235.1670 and mention the DIA event. The hotel is located at 8120 Wisconsin Avenue, Bethesda, MD 20814, USA.
|
Meeting
| Member Standard | $1310.00 | | Member Industry: 3-day Package with 10032 | $1810.00 | | Member Standard (As of 09/22/2010) | $1460.00 | | NonMember Industry: 3-day Package with 10032 | $1950.00 | | NonMember Standard | $1600.00 | | Charitable Nonprofit/Academia Member | $730.00 | | Member Academia: 3-day Package with 10032 | $925.00 | | Charitable Nonprofit/Academia Nonmember | $870.00 | | NonMember Academia: 3-day Package with 10032 | $1065.00 | | Member Government | $580.00 | | Member Government: 3-day Package with 10032 | $725.00 | | NonMember Government: 3-day Package with 10032 | $865.00 | | NonMember Government | $720.00 |
Group Discounts:
Register three individuals from the same company and receive complimentary registration for a 4th! All four individuals must register and prepay at the same time – no exceptions.
To take advantage of this offer, click on “View PDF” below and make four copies of the registration form. Complete the main registration 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.
|
|
|
|
|
|
|
|
|
|
|