DIA | Regulatory Affairs Portal

PDUFA/UFA Conference Recordings on Sale

Purchase both conferences for only $499!

In Fall 2012 DIA, along with FDA and the Food & Drug law Institute (FDLI), hosted Unwrapping FDA's 2012 UFA Package: What’s Inside the Statute, What’s Next? and DIA/FDA Industry PDUFA V Conference in Washington, DC. If you missed these two conferences, you can now purchase synchronized audio recordings and Powerpoint slides. Individual sessions are also available.

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This one-stop resource provides you with the comprehensive knowledge resources in regulatory affairs to help you develop skills and learn proven strategies and techniques to help you overcome the challenges you face in your profession.

This resource center addresses all of today’s hottest topics, including:

US and European regulatory affairs
Preparing for FDA meetings
Post-approval regulatory requirements
Regulatory requirements for product labeling & advertising
Biologic products
Regulatory strategy
Quality assurance

Featured Event

	DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science June 23-27 \| Boston, MA

Meetings

	The Development of Live Biotherapeutics September 24 \| Rockville, MD
	DIA/FDA Oligonucleotide-based Therapeutics Conference September 25-27 \| Washington, DC
	Optimizing Expectations and Success in Support of First-in-Human Trials (FIH) with Stem Cell Therapies September 26-27 \| Washington, DC
	Clinical Trial Disclosure: Towards a More Transparent World October 1-2 \| Bethesda, MD
	US Conference on Rare Diseases and Orphan Products October 7-9 \| North Bethesda, MD
	Drug-Induced Injury of Liver, Heart, Kidney, and Skin: Employing Recent Advances to Improve Patient Safety and Speed Up the Pipeline October 15-17 \| North Bethesda, MD
	EDM and ERS/eCTD: Impact of e-Initiatives on Content and Context October 16-17 \| San Deigo, CA
	Developing Global Animal Health Products to Support Food Security and Sustainability October 17-18 \| Arlington, VA
	DIA's Annual Canadian Meeting: New Reality/New Frontiers October 29-30 \| Ottawa, ON, Canada
	Pharmacovigilance and Risk Management Strategies 2014 January 13-15 \| Washington, DC

In-Person Instruction

	Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum August 12-14 \| Boston, MA
	Regulatory Affairs: The IND, NDA, and Postmarketing August 12-15 \| Boston, MA
	Clinical Project Management August 12-13 \| Boston, MA
	New Drug Product Development and Life Cycle Management August 12-15 \| Boston, MA
	Art of Writing a Clinical Overview September 9 \| Horsham, PA
	Regulatory Affairs for Biologics September 23-24 \| Horsham, PA
	Clinical Statistics for Nonstatisticians October 7-8 \| Horsham, PA
	Global Considerations for Regulatory Strategy Development October 17-18 \| Horsham, PA
	Postmarketing Drug Safety and Pharmacovigilance October 21-22 \| Horsham, PA
	Navigating Chemistry, Manufacturing & Controls Through the Drug Development Process November 4-5 \| Horsham, PA
	Risk Management and Safety Communications Strategies November 4-5 \| Horsham, PA
	Preparing for a US FDA Advisory Committee Meeting November 10 \| Philadelphia, PA
	Regulatory Affairs: The IND, NDA, and Postmarketing November 11-14 \| Philadelphia, PA
	The Leadership Experience November 11-13 \| Philadelphia, PA

Online Learning

	Drug & Cosmetic Rule Amendments: Changes in Regulations Governing Clinical Trials in India June 6
	Assessing the Benefits and Risks of Medicines: Webinar Series - Part 7: A Structured, Quantitative Health Outcomes Approach to Drug Benefit-Risk Analysis June 12
	Regulating a Social World July 18
	Assessing the Benefits and Risks of Medicines: Webinar Series- Part 8: Visualization and Communication of Benefit-Risk July 24
	Planning and Managing Your Project Begins September 10
	Implication of Comparative Effectiveness Research for Clinical Research Organizations September 18
	Change Management, Issues Management, Escalation Management September 18
	Preparing a Clinical Trial Budget October 2
	Basics of the NDA Begins October 22
	Negotiation and Influence October 30
	Team Building and Development November 6
	Project Risk Management: Dealing with the Certainty of Uncertainty November 7

Resources

	View complete catalogue of eLearning Modules.
	View Clinical Safety and Pharmacovigilance Brochure

	View Regulatory Affairs Brochure Preparing for FDA Advisory Committee Meetings, Pete Taft, October 2011 FDA Releases Long Awaited Guidances on Biosimilars, Carol Danielson, April 2012 FDA Moves Forward with Biosimillars Guidance, Carol Danielson, June 2012

Get the Big Picture of DIA’s Training Offerings:

What is Regulatory Science?

Listen to top FDA officials and scientists explain the fields of research that make it possible for FDA to fulfill its mission of protecting public health.

Visit Multimedia Center

Featured Event

	DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science June 23-27 \| Boston, MA

Meetings

	The Development of Live Biotherapeutics September 24 \| Rockville, MD
	DIA/FDA Oligonucleotide-based Therapeutics Conference September 25-27 \| Washington, DC
	Optimizing Expectations and Success in Support of First-in-Human Trials (FIH) with Stem Cell Therapies September 26-27 \| Washington, DC
	Clinical Trial Disclosure: Towards a More Transparent World October 1-2 \| Bethesda, MD
	US Conference on Rare Diseases and Orphan Products October 7-9 \| North Bethesda, MD
	Drug-Induced Injury of Liver, Heart, Kidney, and Skin: Employing Recent Advances to Improve Patient Safety and Speed Up the Pipeline October 15-17 \| North Bethesda, MD
	EDM and ERS/eCTD: Impact of e-Initiatives on Content and Context October 16-17 \| San Deigo, CA
	Developing Global Animal Health Products to Support Food Security and Sustainability October 17-18 \| Arlington, VA
	DIA's Annual Canadian Meeting: New Reality/New Frontiers October 29-30 \| Ottawa, ON, Canada
	Pharmacovigilance and Risk Management Strategies 2014 January 13-15 \| Washington, DC

In-Person Instruction

	Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum August 12-14 \| Boston, MA
	Regulatory Affairs: The IND, NDA, and Postmarketing August 12-15 \| Boston, MA
	Clinical Project Management August 12-13 \| Boston, MA
	New Drug Product Development and Life Cycle Management August 12-15 \| Boston, MA
	Art of Writing a Clinical Overview September 9 \| Horsham, PA
	Regulatory Affairs for Biologics September 23-24 \| Horsham, PA
	Clinical Statistics for Nonstatisticians October 7-8 \| Horsham, PA
	Global Considerations for Regulatory Strategy Development October 17-18 \| Horsham, PA
	Postmarketing Drug Safety and Pharmacovigilance October 21-22 \| Horsham, PA
	Navigating Chemistry, Manufacturing & Controls Through the Drug Development Process November 4-5 \| Horsham, PA
	Risk Management and Safety Communications Strategies November 4-5 \| Horsham, PA
	Preparing for a US FDA Advisory Committee Meeting November 10 \| Philadelphia, PA
	Regulatory Affairs: The IND, NDA, and Postmarketing November 11-14 \| Philadelphia, PA
	The Leadership Experience November 11-13 \| Philadelphia, PA

Online Learning

	Drug & Cosmetic Rule Amendments: Changes in Regulations Governing Clinical Trials in India June 6
	Assessing the Benefits and Risks of Medicines: Webinar Series - Part 7: A Structured, Quantitative Health Outcomes Approach to Drug Benefit-Risk Analysis June 12
	Regulating a Social World July 18
	Assessing the Benefits and Risks of Medicines: Webinar Series- Part 8: Visualization and Communication of Benefit-Risk July 24
	Planning and Managing Your Project Begins September 10
	Implication of Comparative Effectiveness Research for Clinical Research Organizations September 18
	Change Management, Issues Management, Escalation Management September 18
	Preparing a Clinical Trial Budget October 2
	Basics of the NDA Begins October 22
	Negotiation and Influence October 30
	Team Building and Development November 6
	Project Risk Management: Dealing with the Certainty of Uncertainty November 7

Resources

	View complete catalogue of eLearning Modules.
	View Clinical Safety and Pharmacovigilance Brochure

	View Regulatory Affairs Brochure Preparing for FDA Advisory Committee Meetings, Pete Taft, October 2011 FDA Releases Long Awaited Guidances on Biosimilars, Carol Danielson, April 2012 FDA Moves Forward with Biosimillars Guidance, Carol Danielson, June 2012

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PDUFA/UFA Conference Recordings on Sale

Bring Any DIA Training Course to Your Company!

Regulatory Affairs Portal

What is Regulatory Science?

Bring Any DIA
Training Course to Your Company!