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Using Pharmacokinetic and Pharmacodynamic Principles to Enable IND and NDA Submissions

Nov 29 2012 8:00AM - Nov 30 2012 4:45PM | Hilton Crystal City at Washington Reagan National Airport 2399 Jefferson Davis Hwy. Arlington, VA 22202

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Overview 

When it comes to submitting an IND or NDA to the FDA, there are many scientific criteria that need to be met as well as a thorough understanding of clinical pharmacology and pharmacokinetic concepts and regulatory requirements. The agenda for this course is structured based on the building blocks for the Clinical Pharmacology reviewing discipline and associated FDA guidelines. This course brings together faculty from both industry and FDA to share strategies for compliance with biopharmaceutic and pharmacokinetic requirements to successfully file an IND and NDA. This course will allow ample time for questions and interaction with industry and FDA representatives.

What You Will Learn 

  • Bioanalytical requirements
  • Biopharmaceutics considerations
  • Bioequivalence guidance
  • Metabolic and transporter phenotyping
  • Clinical drug-drug interaction assessments
  • Pharmacogenomics principles
  • Pharmacokinetics in special populations
  • Pharmacometrics applications
  • Unique PK-PD aspects of biologics
  • QTc timing and impact

Who Should Attend 

Professionals involved in:

  • Regulatory affairs
  • Clinical research
  • Clinical pharmacology
  • Pharmacokinetics/pharmacodynamics
  • This course will also be valuable for FDA reviewers and other FDA staff

Learning Objectives 

Participants who complete this course should be able to:

  • Identify the biopharmaceutic and pharmacokinetic requirements needed to successfully file an IND and NDA submission
  • Define pharmacokinetic parameters to report study outcomes
  • Recognize the importance of the bioequivalence data analysis
  • Differentiate biologics from small molecules in drug development
  • Describe the value of pharmacogenomics and pharmacometrics in regulatory applications

Special Offers 

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

Hotel & Travel 

Hilton Crystal City at Reagan National Airport
A limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until October 29, 2012, or until room block is filled). Attendees should make airline and room reservations as soon as possible.
Standard Room Rate
$209
Address: 2399 Jefferson Davis Highway, Arlington, VA  22202
Phone: +1-703-418-6800
When making reservations, mention the DIA training course.
Located within minutes of downtown Washington, DC, Historic Alexandria, Georgetown, and the Pentagon, this hotel offers free shuttle service daily to and from Ronald Reagan Washington National Airport (DCA); the Crystal City Metro station; and nearby shopping, restaurants, and businesses. The national monuments, government agencies, and museums (many offering free admission) are accessible via the Metro or are within walking distance.

Contact Information 

Registration
Vicki Adkinson
Phone: +1-215-442-6162
Email: Vicki.Adkinson@diahome.org
Agenda and Event Details
Colleen Buckley
Phone: +1-215-442-6108
Email: Colleen.Buckley@diahome.org

Faculty 

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Continuing Education 

The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The Drug Information Association designates this educational activity for up to 15.25 contact hours or 1.525 CEUs. Type of Activity: Knowledge
ACPE Credit Allocation:
Day 1: 286-000-12-087-L04-P, 8 contact hours or .8 CEUs:
Day 2: 286-000-12-088-L04-P, 7.25 contact hours or .725 CEU


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 1.5 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.

Name Credit Type Max Credits CEU
Using Pharmacokinetic and Pharmacodynamic Principl ACPE 15.25 1.525
Using Pharmacokinetic and Pharmacodynamic Principl IACET 15.25 1.500

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.

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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