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FDA ADCOMs
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CRLs / FDRRs / MDLs
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NDA / BLA / PMA Clinical Modules
ACIP Meetings & Working Groups
IR Support
EMA-CHMP
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SAG, AHEG & PRAC Meetings
Day 120 / 180 / 195 Questions
Clarification Meetings & Rapporteur Meetings
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Taking the Proactive Path to Approval – The Strategic Advantage of Early Messaging in FDA Submissions
Book Review: The FDA Survival Manual – A Step-by-Step Guide to Preparing for a Successful ADCOM, 2nd Edition
Pink Sheet: Current, Former US FDA Adcomm Members' Reform Idea: Allow Conflicted Experts To Participate
New Survey of 400+ FDA Advisory Committee Members Weigh in on Recommendations for Reforms
Every Speech is an Opportunity for Greatness. Seize It.
Public Comment: Optimizing FDA’s Use of and Processes for Advisory Committees
Webinar: Taking Q&A with Regulators to the Next Level
Webinar: CHMP OEs and FDA ADCOMs – Navigating the Differences to Prepare for Success
Want to Succeed at Your FDA Advisory Committee Meeting? Don’t Ignore the Power of a First Impression
Going Back to the Basics of Effective Communications – How Manufacturers Should Approach Medicare’s Drug Price Negotiation Program
Leveraging an Investigative Reporting Toolbox – An Untraditional Approach to Media Training
Aligning a Corporate Narrative—and Leaders—for Effective Communications
Book Review: The CHMP Meeting Survival Manual –
A Step-by-Step Guide to Succeeding at Regulatory Meetings for Marketing Authorization
Book Review: The FDA Clinical Submission Survival Manual
Book Review: The FDA Advisory Committee Survival Manual
Taking a Strategic Approach Early to Overcome Regulatory Hurdles and Win Approval
Pink Sheet: Advisory Committee Disagreement With US FDA On Approval Decisions An Increasingly Rare Event
Secrets of a Speechwriter: A Thought Processor for Thought Leaders
RAPS RF Quarterly: Patient-reported outcomes and patient preference information in regulatory decision making
Getting Ready For Launch In A Virtual Reality When Conventional Rules No Longer Apply
How to Cure Message Masquerade
Why Most Business Messages Are Lame
Do You Suffer from Message Masquerade?
Pink Sheet: Adcomm Member Survey Shows Continued Support For Virtual Meetings After Pandemic
Pink Sheet: Power To The (Adcomm) People: Members Believe Votes Should More Directly Affect US FDA Decisions
Delivering Under Pressure – How To Turn Your Data Into An Investor And Media Success Story
To Zoom or not to Zoom? That is the Question: For the FDA and US sponsors, the answer may depend on the type of FDA meeting
Pink Sheet: How To Win Over The EU CHMP At Virtual Meetings
How To Break Through The Technology And Help Health Educators Connect And Communicate Virtually With Providers And Patients
Time to Get Real About Real-World Evidence – More Action, Less Talk Could Accelerate Access to New Medicines, Pharma Industry Experts Say
Setting Up An Association President To Be A Virtual "Overnight" Sensation
What You Need to Know About Application Orientation Meetings (Part 2): How to Prepare for Success
What You Need to Know About Application Orientation Meetings (Part 1): Laying the Foundation
The Stakes Don’t Get Higher Than This: Racing Against the Virus to Help Moderna’s COVID-19 Vaccine Receive Emergency Use Authorization
Rethinking A Biotech's Investor And Media Communications Strategy
Op-Ed: Leading by Example on COVID Vax Won't Sway Black Community
Time for Change? Has the Time Come for the Pharmaceutical Industry to Accept Modest Prices?
Reaching Diverse Stakeholders With An Aligned Story For Product Launch Success Worldwide
Webinar: A Rare Behind-the-Scenes Look at CHMP Meetings – Challenges, Opportunities, and the One Shot You Have at Winning
When Addressing CHMP Major Objections, Don’t Forget About Benefit-Risk
Leveraging Communications To Help A Nonprofit Stand Out And Motivate Donors To Give – And Give Some More – To The Cause
Gaining Market Authorisation in Europe: Responding to Complex EMA Questions When You’re on the Clock
CHMP Meeting Success: Providing Clinical Perspective to Overcome Major Objections
Making it Count – Turning Complex Data into a Story with Impact
The Art of Effectively Managing Virtual Presentations and Meetings
Leadership in the Pandemic
Cindy DiBiasi on CEOs Speak Podcast
How To Align Disjointed Company Messages And Tell A Focused Brand Story Across The Entire Enterprise
Episode 61: Preparing for Virtual High-Stakes Meetings
Session 12: How To Work With The US FDA When You Can’t Meet With Them
How To Turn A Crisis Into An Opportunity – And Change The Way A Company Communicates
COVID-19: Will it be a Catalyst that Moves us Forward in the Drug-Pricing Debate?
Boosting Your Virtual Executive Presence
Dazzling the Lifeless Lens, or How to Give the Best Speech of Your Life, Virtually
Virtual US FDA Advisory Committees May Have One Silver Lining: Available Experts
How We Plan to Rebuild in the Post COVID Economy
A New Kind of FDA Meeting
Our Statement on Racial Injustice and Systemic Racism
Webinar: How to Effectively Communicate with FDA and EMA Regulators – In a Virtual Meeting Environment
How To Work From Home & Keep Your Job
Conducting a Successful Mock Meeting, Virtually: Case Study
COVID-19, Communications and Leadership: What We’re Seeing on the Front Lines
Top 10 Tips on Why Visuals Matter More in Today’s “Virtual” Reality
Top 10 Tips on How to “Bring It” in Today’s Virtual Reality
Top 10 Tips for Effective Virtual Meetings
Celebrating International Women’s Day: What Today’s Women Executives Need to Know About Excellence in Communications
Winning Minds – and Hearts – in Today’s Business Communications
Storytelling for Executives – How to have IMPACT
Keep Calm and Moderate On: The Makings of a Successful Moderator
Investing in Sustainable Healthcare: Part 1
The Debrief on Briefing Documents: How to Maximize Your Briefing Book for FDA Advisory Committee Meetings
Maximizing the Effectiveness of Data Visualizations in Regulatory Submissions
CHMP Meetings: A Rare Behind-the-Scenes Look at These Private European Regulatory Meetings
Investing in Sustainable Healthcare: Part 2
Recruiting for a Realistic Mock Advisory Committee Meeting
Running a Realistic Mock FDA Advisory Committee Meeting
Top 10 Rules for Effectively Communicating With Regulators
Do Public Hearing Participants Influence Outcomes of FDA Advisory Committee Meetings?
Seven Steps for Success at FDA Meetings
Five Steps to Writing an Effective Presentation for an FDA Advisory Committee Meeting
Five Steps to Delivering an Effective Presentation at an FDA Advisory Committee Meeting
Preventing and Accounting for Missing Clinical Trial Data for FDA Drug Approvals. Part 1: Prevention
Preventing and Accounting for Missing Clinical Trial Data for FDA Drug Approvals. Part 2: Analysis
Top 10 Tips for Successful Meeting Planning
How to Identify and Organize a Winning Team for Your FDA Advisory Committee Meeting
Tips for Medical Science Liaisons: It’s Not Only About How Much You Know
How to Maximize Your FDA Advisory Committee Preparation Team Regardless of Size
Six Ways to Keep Your Team Motivated During ADCOM Preparation
Path to CDRH Approval: Practices and Preferences of FDA Medical Device ADCOM Members
Preparing for Regulatory Submission: Analyzing Clinical Data to Strengthen the Benefit-Risk Profile
Post-Marketing Plans: An Often-Overlooked Component of FDA Advisory Committee Meeting Discussions
CDER Expedited Pathways: Why Do Some Drugs Get Approved Quicker than Others?
Anticipating Common Questions During an Rx-to-OTC Switch
Impact of Evaluation and Reporting of Age, Race, and Ethnicity on Medical Device Clinical Trials
Avoiding Common Pitfalls at FDA Device Panel Meetings
FDA NDA to ADCOM: Five Tips to Ensure a Smooth Transition
The Danger of Company Groupthink in FDA Advisory Committee Preparations
How to Maximize Early FDA Interactions and Improve Your Chances of Medical Device Approval
Webinar: Winning from the Beginning: Best Practices to Increase Your Chances for Successful CHMP Meetings
Webinar: Winning from the Beginning: Best Practices to Increase Your Chances for First-Pass Approvals in Key Markets
Webinar: From Mild-Mannered Scientist to Communications Ironman
Cross-Cultural Communication: Seven Tips to Prevent Miscommunication and Align Your Team
Down with UpTalk: The Viral Voice Trend Threatening Business Leaders’ Credibility
Presentation Tips: How to Make It Your Own (Even When It’s Not)
Presentation Tips: Writing for the Ear
Speaker Training From the Inside Out
Great Communication Starts with Great Messaging
Taking the “E-A-R-L-Y Train” for Crisis Management
Active Listening Can Make You a Better Speaker: Part 1
What Today’s Business Leaders Can Learn from a “Powerless” Woman Who Spoke Her Truth
Communications Myths: Five Untruths that Can Get You in Trouble
Active Listening Can Make You a Better Speaker: Part 2
Visual Storytelling with PowerPoint: Tips for Communicating Complex Data Clearly
Executive Speaking Success: Tips for Healthcare Leaders
Webinar: FDA Advisory Committee Prep: Steps for Success
FDA Advisory Committee Member Practices and Preferences: A Survey on CDER Panel Member Influences
FDA Advisory Committee Meetings: What They Are, Why They Happen, and What They Mean for Regulatory Professionals