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What To Do When An Influential Doctor Launches A Social Media Rampage Against Your Over-The-Counter Product

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

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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: 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

Listening and Empathy – The Answers to Pandemic-Induced Stress

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 Communications 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

A Winning Combination: Holistic Access Strategies and Strong Leadership

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

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Top 10 Rules for Effectively Communicating With Regulators

Do Public Hearing Participants Influence Outcomes of FDA Advisory Committee Meetings?

Achieving Approval for Abuse-Deterrent Opioids in the Era of an Opioid Epidemic

Getting Access Right: Break Down Pharma’s Silos and Convene the Stakeholders

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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

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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

Growing the Choir: More Voices Joining the Healthcare Value Conversation

Book Review: The FDA Clinical Submission Survival Manual

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

Book Review: The FDA Advisory Committee Survival Manual

Crisis Communications: The Insider’s Guide for Dealing with “60 Minutes”

Cross-Cultural Communication: Seven Tips to Prevent Miscommunication and Align Your Team

Down with UpTalk: The Viral Voice Trend Threatening Business Leaders’ Credibility

The “60 Minutes” Formula: How to Protect Yourself from the Toughest Interview on TV

Presentation Tips: How to Make It Your Own (Even When It’s Not)

The Art of Moderating and Lion Taming

Presentation Tips: Writing for the Ear

Creating Leaders Who Communicate with Authenticity

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

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