American Course Drug Development and Regulatory Sciences
- Faculty Lecture: "Preparing Focused and Effective Regulatory Communications"
- Faculty Lecture: "Preparing for an FDA Advisory Committee"
American Association for the Treatment of Opioid Dependence
- "Countering Opioid Stigma: Communicating Messages to Influence Public Perception"
BIO International Conference
- Business Development Course: "Communicating the Deal: Achieving Positive Outcomes"
Biotechnology Industry Organization - Licensing Executives Society
- Business Development Course: "Communicating the Deal"
Ernest Mario School of Pharmacy at Rutgers University
- Presentation Excellence for PharmD Candidates
European Center for Pharmaceutical Medicine
- Case Study: "How to Prepare a Scientific Advice Session"
- Faculty Lecture: "Preparing Regulatory Communication"
- Faculty Lecture: "Creating Gold Standard Investigator Meetings"
- "PRO in Regulatory Submissions & Launch," with Jean Paty, PhD.
- Case Study: "The Role of PRO in Successful Product Differentiation"
- Webinar: "Using PROs to Optimize Comparative Effectiveness Trials"
Regulatory Affairs Professionals Society (RAPS)
- Annual Exhibitor at RAPS Conference
- Conference Session: "How to Win Friends and Influence People: Using Professional Development to Refine Communication Skills and Increase Professional Value"
- Conference Session: "Preparing for a Combination Product Advisory Committee"
- Conference Session: “Developing an Advisory Committee Strategy”
- Conference Session: “How to Prepare for a Health Authority Meeting: US and Europe"
- Conference Session: “Getting the Story Straight: Creating Messages for Submission Documents (NDA, BLA, PMA)"
- Conference Roundtable: "The Advisory Committee Briefing Document: A New Genre"
- Conference Roundtable: "The Critical Path to a Successful FDA Advisory Committee Meeting"
- RAPS Focus Magazine: "Raising the Regulatory Voice"
- Webinar: "Using Professional Development to Refine Communication Skills and Increase Professional Value"
- Webinar: "Best Practices for Communicating with Regulatory Agencies in EU / Canada"
- Webinar:“Giving Voice to Regulatory Leadership”
Society of Toxicologic Pathology
- Presentation: "Presentation Skills and Scientific Advocacy"
- Workshop: STP Career Development
University of California, Santa Cruz and San Jose State University
- Continuing education lectures on regulatory communication
Wall Street Unplugged: Munich, Germany; New York City
- "From IND to AdComm with Your Scientific Narrative"
- "Truth, Science, and Health Authorities: The Role of Messages in Drug Development"
- "Harmonizing Strategy and Tactics for an FDA Advisory Committee." In Global Pharmaceutical and Biologics Regulatory Strategy, Monica Siegenthaler, PhD & William Sietsema, PhD, Editors.
- "Preparing for FDA Advisory Committee Meetings." In Expediting Drug and Biologics Development, Third edition, Chapter 34, Steven E. Linberg, Ph.D., Editor.
- "The FDA Product Advisory Committee: An Overview." In Preparing the New Drug Application: Managing Submissions Amid Changing Global Requirements, William Sietsema
If you'd like one of our ECG consultants to present to your group or association, please contact the ECG Team here.