DIA/FDA Tailored Therapeutics: Practical Issues and Methodologies for Selecting the Right Patients,

DIA/FDA Tailored Therapeutics: Practical Issues and Methodologies for Selecting the Right Patients

Oct 25 2011 8:00AM - Oct 26 2011 4:00PM
Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road
North Bethesda, MD 20852

Interest Area(s):
Clinical Safety/Pharmacovigilance,Clinical Research,Comparative Effectiveness/Health Technology Assess,Pharmacology,Nonclinical,Medical Communications,Quality Assurance/Quality Control,Regulatory Affairs,Statistics,Clinical Data Management/ eClinical

Overview:
This multi-disciplinary conference provides an opportunity to increase awareness,communicate shared experiences, and clarify terminology regarding tailored therapeutics across the stages of drug development, including:

• Topics of response guided therapy
• Biomarkers
• Diagnostic tests
• Clinical trial operational and regulatory issues
• Personalized medicine

Regulatory Affairs Part II: The NDA Phase (training course)

Don't miss this training course titled, "Regulatory Affairs Part II: The NDA Phase"

Date(s) And Time(s):
Oct 17 2011 8:30AM - Oct 19 2011 3:45PM

Location:
Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509

Interest Area(s):
Regulatory Affairs,Clinical Research,Professional Education, Training & Development

Overview:
Basics of NDA Submission and Post-marketing Regulatory Requirements

Gain insight into the regulatory background of the NDA, preparing an NDA, and postapproval activities. The course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, or traditional biologics.

Regulatory Affairs: Part 1: The IND Phase (training course)

If you're interested in pursuing a career in regulatory affairs, don't miss this DIA training course titled, Regulatory Affairs: Part 1: The IND Phase

Dates: Sep 21 2011 8:30AM - Sep 23 2011 12:15PM

Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509

Interest Area(s): Clinical Research,Professional Education, Training & Development,Regulatory Affairs

Overview:
All You Need to know about IND Submissions in Only 3 Days

Learn how to apply regulatory concepts to ensure compliant IND submissions to FDA. The course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, or traditional biologics.

Get ready for DIA 2011

DIA 2011 Features the Most Diverse Exhibit Hall and Comprehensive Program Anywhere
47th Annual Meeting
June 19-23, 2011
Chicago, IL

Tracks

DIA 2011 is the largest multidisciplinary event for professionals involved in the discovery, development,
and life cycle management of pharmaceuticals, biotechnology, medical devices, and related
health care products. This year’s event will help you develop a holistic and integrated program for
your entire team while increasing their access to training and expanded professional opportunities.

Track 1>> Clinical Operations
Track 2>> Development Planning
Track 3>> Outsourcing Strategies and Innovative Partnering Models
Track 4>> Nonclinical and Early Clinical Translational Development
Track 5>> Product Advertising and Communications
Track 6>> Medical Writing and Communications
Track 7>> IT Methods and Technologies
Track 8>> Research Data and Content Management
Track 9>> Regulatory Affairs and Science, Quality and GXP Compliance
Track 10>> Public Policy/Health Care Compliance
Track 11>> Clinical Safety and Pharmacovigilance
Track 12>> Statistics
Track 13>> Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
Track 14>> Medical Devices
Track 15>> Professional Development
Track 16>> Global Agency Track
Track 17>> SIAC Showcase
Track 18>> Late-breaking Topics

FDA/DIA Statistics Workshop 2011

FDA/DIA Statistics Forum 2011

Date(s) And Time(s):  Apr 11 2011 8:00AM - Apr 13 2011 3:35PM

Location:
Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road
North Bethesda, MD 20852

Interest Area(s):
Statistics,Clinical Research,Professional Education, Training & Development,Clinical Safety/Pharmacovigilance,Medical Communications,Regulatory Affairs,Research & Development

Overview:
An Open Forum to Discuss Important Statistical Issues Associated with the Development and Review of Therapeutic Drugs and Biologics.

Don’t miss your annual opportunity to learn about and discuss the current and emerging statistical methodologies and quantitative approaches used to develop evidence of the efficacy and safety of new drug and biologic therapeutic products.

DIA's Regulatory Affairs Certificate Program

DIA's Regulatory Affairs Certificate Program provides you with comprehensive training on current regulations and their practical application to the development and commercialization of pharmaceutical, biotechnology, medical device, and related health care products. 

Features and Benefits

* Our world-class faculty address the practical and theoretical aspects of the conduct of pharmacovigilance, with emphasis on understanding of the concepts, themes underlying effective processes, and the basic tenets of global regulatory compliance with safety principles.
* DIA is an established, recognized authority in the pharmaceutical industry and has been for more than 47 years.
* As an independent, not-for-profit, global association of members with no corporate sponsors, DIA offers an objective program that results in a DIA Certificate of Completion.
* Many courses offer Continuing Education Credits.

What You Will Learn:

* US regulatory affairs: the IND and NDA/CTD phases
* EU regulatory requirements
* Preparing for FDA meetings
* Post-approval regulatory requirements
* Regulatory requirements for product labeling & advertising
* Regulatory courses covering drug, medical device, and biologic products
* Quality assurance
* Much more!

DIA (Drug Information Association)

DIA is a neutral, nonprofit, global, professional association of nearly 18,000 members who work in every facet of the discovery, development, and life cycle management of pharmaceuticals, medical devices, and related products.

DIA is committed to the broad dissemination of information among our members, with continuously improved professional practice as the goal. DIA serves our members in a neutral, global environment that operates independent of the influence of any one organization or authority.

DIA operates as a financially independent nonprofit organization that funds itself from meeting and membership fees. The voluntary efforts of DIA members and speakers allow DIA to provide programs and publications to members at a reasonable, competitive cost.

Medical Communications Workshop 2011

22nd Annual Workshop on Medical Communications
Core Curriculum March 7 & 8 | Pre-workshop Tutorials March 8 | Workshop March 8-10
La Costa Resort & Spa, Carlsbad, CA

Sharpen your medical communications skills to maximize your effectiveness.

SESSION TOPICS:
• Regulatory Review
• Riding the Inspection/Audit Wave
• Medical Communications Experience with Risk
• Evaluation and Mitigation Strategies (REMS)
• Using Virtual Solutions

BREAKOUT SESSIONS:
• Medical Communications Responses: What’s Everyone Sayin’
• Statistics
• How to Lead and Deliver Value As a Medical Science Liaison
• Evidence-based Medicine
• Medical Information Support: Determining Service Levels for Expanded Access Programs, Investigational, and Post-patent Expiry Products
• Quality Monitoring Methods and Strategies for Contact Centers
• Medical Communications at Medical Congresses
• Medical Science Liaison Management
• Mergers and Acquisitions
• Global Integration
• Medical Communications and Managed Care Customers
• Today’s Pharma Contact Centers
• Copyright Challenges

Non-clinical physician careers in drug development

If you're interested in a career in drug development, you may want to consider receiving some official training/education. Here are some examples of DIA (Drug Information Association) courses you may wish to consider:

INSTRUCTOR-LED TRAINING:

Clinical Statistics for Nonstatisticians
September 10-11 | Baltimore, MD

Regulatory Affairs Part I: The IND Phase
September 14-16 | Philadelphia, PA

The Leadership Experience
September 21-24 | Philadelphia, PA

High Performance Biopharm Teams
September 22-23 | Horsham, PA (DIA Headquarters)

Drug Safety Surveillance and Epidemiology
September 22-24 | Baltimore, MD

Fundamentals of Clinical Research Monitoring
September 22-24 | Baltimore, MD

New Drug Product Development and Lifecycle Management
September 24-25 | Horsham, PA (DIA Headquarters)

ONLINE TRAINING SERIES:

Developing Standard Operating Procedures (SOPs)
Three-part series begins September 15

Development of a Clinical Study Report
Three-part series begins September 29

Overview of Drug Development
Three-part series begins September 30

Fundamentals of Project Management for the Nonproject Manager
Four-part series begins October 1

Who's Monitoring the Monitor
Three-part series begins October 5

DIA is a nonprofit, multidisciplinary association that provides a neutral forum for sharing information that optimizes the process of drug development and lifecycle management through:

• Global and regional forums for the exchange of information, education and training;
• Extensive multidisciplinary networking opportunities;
• Rewarding volunteer leadership experiences; and
• High-quality professional development opportunities.

Visit the DIA here: http://www.diahome.org