Канал: The Weinberg Group

How to Maximize the Benefit of Your Pre-IND Meeting & Translate it into Success in Europe

How to Maximize the Benefit of Your Pre-IND Meeting & Translate it into Success in Europe

Outsourcing Functions Doesn't Mean You've Outsourced Compliance Obligations

Outsourcing Functions Doesn't Mean You've Outsourced Compliance Obligations

Critical Components of Quality Management Systems

Critical Components of Quality Management Systems

Why the FDA Should Never Be Your First Inspection

Why the FDA Should Never Be Your First Inspection

The Truth Can Hurt But Hearing It At The Right Time Can Save Millions

The Truth Can Hurt But Hearing It At The Right Time Can Save Millions

Finding a Roadmap to Approval Hint, You Can't Pick One Up at the FDA

Finding a Roadmap to Approval Hint, You Can't Pick One Up at the FDA

Generic Failure: Why 90% of ANDAs Are Rejected on the First Pass

Generic Failure: Why 90% of ANDAs Are Rejected on the First Pass

Getting Meetings Right: How to Prepare for Type B Meetings with the FDA

Getting Meetings Right: How to Prepare for Type B Meetings with the FDA

It's the FDA, Not the NBA: Why No Drug Gets That Slam Dunk Approval

It's the FDA, Not the NBA: Why No Drug Gets That Slam Dunk Approval

Responding to a 483, 15 Days To Panic or Plan for Success

Responding to a 483, 15 Days To Panic or Plan for Success

Taking Advantage of the Orphan Drug Act - Webinar

Taking Advantage of the Orphan Drug Act - Webinar

Single and Shared REMS Systems: The Past, Present and Future Webinar

Single and Shared REMS Systems: The Past, Present and Future Webinar

Increasing GCP Audit Program Efficiency through Outsourcing Webinar

Increasing GCP Audit Program Efficiency through Outsourcing Webinar

Taking Full Advantage of the NDA Pathway Webinar

Taking Full Advantage of the NDA Pathway Webinar

The 505(b)(2) NDA Pathway - An Innovative FDA Strategy that Everyone Should Understand Webinar

The 505(b)(2) NDA Pathway - An Innovative FDA Strategy that Everyone Should Understand Webinar

Overcoming Regulatory, Clinical and Quality Challenges in Developing Combination Products Webinar

Overcoming Regulatory, Clinical and Quality Challenges in Developing Combination Products Webinar

FDA Enforcement -- The Cop is Back -- How Enhanced Enforcement Can Impact You and Your Firm Webinar

FDA Enforcement -- The Cop is Back -- How Enhanced Enforcement Can Impact You and Your Firm Webinar

Drug Safety 2011: What You Need to Know. Bleak House or Great Expectations? Webinar

Drug Safety 2011: What You Need to Know. Bleak House or Great Expectations? Webinar

Advisory Committees- It All Comes Down to This Webinar

Advisory Committees- It All Comes Down to This Webinar

Important Lessons in Developing Biosimilars Webinar

Important Lessons in Developing Biosimilars Webinar

FDA User Fees- What Have They Done for You Lately? Webinar

FDA User Fees- What Have They Done for You Lately? Webinar

Evaluating Product Risk in a Rapidly Changing Environment Webinar

Evaluating Product Risk in a Rapidly Changing Environment Webinar

Generic Drug User Fees (GDUFA)- How do they Impact ANDA Holders and Type II DMF Holders? Webinar

Generic Drug User Fees (GDUFA)- How do they Impact ANDA Holders and Type II DMF Holders? Webinar

New Biosimiliars Guidance- Has Anything Changed? Webinar

New Biosimiliars Guidance- Has Anything Changed? Webinar

Maximizing Audit Efficiencies while Utilizing EDC Webinar

Maximizing Audit Efficiencies while Utilizing EDC Webinar

ANDA vs. 505(b)(2): When and Why? Webinar

ANDA vs. 505(b)(2): When and Why? Webinar

Understanding What FDA is Looking for in Postmarket Safety Assessments: Going Beyond AERS Webinar

Understanding What FDA is Looking for in Postmarket Safety Assessments: Going Beyond AERS Webinar

Ensuring Successful FDA Meetings Webinar

Ensuring Successful FDA Meetings Webinar

It's All in the Details: Tips for Ensuring a Successful NDA Filing Webinar

It's All in the Details: Tips for Ensuring a Successful NDA Filing Webinar

Clinical Data Management and the Cult of Quality Webinar

Clinical Data Management and the Cult of Quality Webinar

Orange Book as a Strategic Resource Webinar

Orange Book as a Strategic Resource Webinar