I enjoy speaking to large and small groups about several regulatory topics. Whenever I take on a speaking engagement, I always do the work to identify the audience’s needs and the best way to relate to them. Over the past few years I have given talks, solo or in partnership with esteemed colleagues, on a variety of topics, including the following:

  • Fundamentals of the FDA Regulatory Processes for Small Molecule Drugs
  • FDA Regulatory Processes for Medical Devices 101: a Primer
  • FDA Regulatory Processes for Biologics and Biosimilars
  • From Proof-of-Concept to Market: How a Few Make it and Why Many Don’t
  • Regulatory and Scientific Writing: A Hands-on Class for Professionals in the Regulated Industry
  • An Eight-Step Guide To Developing Your First Healthcare Product

…and more.  My style combines well-vetted data, easily digestible insights, and actionable recommendations for organizations looking to set the stage for an event, provide an advanced “how-to” session for attendees, or even just to get a different perspective on some thorny problems.

Selected Invited Presentations and Seminars

  • Drago D., Senatore F., Surprising Reasons for Clinical Holds and Successful Practices to Avoid Them! FDA/Xavier Pharmalink, Cincinnati, March 14, 2019.
  • Drago D., Celeste C., Jordan C., and Senatore F., The Secrets of Successful Meetings with Health Authorities—What You Don’t Know May Hurt You. FDA/Xavier Pharmalink, Cincinnati, March 14, 2019.
  • Drago D. Global Registration and Approval Processes – Chemistry, Manufacturing and Controls. European Center of Pharmaceutical Medicine, Basel, Switzerland, February 13, 2019.
  • Drago D. Regulatory and Scientific Writing: A Practical Toolkit. European Center of Pharmaceutical Medicine, Basel, Switzerland, February 12, 2019.
  • Drago D. The Do’s and Don’ts of a Successful FDA Meeting. FDA Advisory Committees Strategy Summit, Herndon, VA, November 5, 2018.
  • Drago D. Important Regulatory and Policy Changes in the Past Year, National Press Club, Washington, DC, October 19, 2018.
  • Panico C., Boyer D., Brown J., Drago D. The Regulatory Profession: Act II. RAPS Convergence, Vancouver, Canada, October 4, 2018.
  • Drago D., Internal Audit Programs: Benefits and Challenges in Implementing a Culture of Self Correction. III Russian GMP Conference, Kazan, Russia, August 28, 2018.
  • Campbell J., Kim G., Koss L. Weininger S., Drago D., Smart Fabrics Standards: A Government Regulator’s Perspective, 2018 US Department of Commerce-IFAI Smart Fabrics Summit, Washington, DC, April 28, 2018.
  • Drago D. Getting Buy-in for Regulatory Compliance. ASQ New Jersey Chapter Spring Quality Conference, March 28, 2018.
  • Drago D. Talking to Regulators and Other Decision Makers. ASQ New Jersey Chapter Spring Quality Conference, March 28, 2018. 
  • White R., Kachel K., Guerrieri T., Drago D. Women in the Workplace: Leadership, Barriers, & Struggles. John Hopkins University Advanced Academic Programs Career Services Summit, March 26, 2018.
  • Drago D., Singer N. Project Management for Successful CFR 117 Integration into MFRPS. MFRPA 2018 Albuquerque, NM, January 30, 2018.
  • Drago D., Alsbury S. A Competency Framework. 2017 TOPRA Symposium, London, UK, October 4, 2017.
  • Drago D. Strengthening Regulatory Systems Through Convergence, Reliance, and Recognition, 2017 Russian GMP Conference, Gelendzhik, Russia, September 18, 2017.
  • Drago D. Compliance is Not Equal to Quality: An Emerging Regulatory Paradigm, 2017 Russian GMP Conference, Gelendzhik, Russia, September 19, 2017.
  • Drago D. The Secrets of Successful Meetings With Authorities: What You Don’t Know May Hurt You, 2017 RAPS: The Regulatory Convergence, National Harbor, MD, USA, September 11, 2017.
  • Drago D. Regulatory Writing: A Hands-on Class for Professionals in the Regulated Industry, 2017 RAPS: The Regulatory Convergence, National Harbor, MD, USA, September 10, 2017.
  • Drago D. Handling Regulatory Challenges, 2017 RAPS: The Regulatory Convergence, National Harbor, MD, USA, September 10, 2017.
  • Drago D. Regulatory Systems in the US, Russian State Institute of Medicines and Good Practices Delegation, Graduate School USA, Washington, DC, July 17, 2017.
  • Drago D. Fundamentals of the Food and Drug Administration Approval Processes, International GLG Series for Financial Analysists, June 29, 2017.
  • Drago D., Roenninger S. EU Approaches to GMPs and Inspections, Modern tendencies in GMP inspections of pharmaceutical manufacturers, SIM & GxP, Moscow, June 27, 2017.

  • Roenninger S., Drago D. Risk-oriented approach towards organization of quality control of medicines, Modern tendencies in GMP inspections of pharmaceutical manufacturers, SIM & GxP, Moscow, June 27, 2017.
  • Kreis J., Ali F., Drago D. Training and Education Opportunities for FDA and Industry Officials, Annual Meeting of the Association of Food and Drug Officials, Huston, TX, June 19, 2017.
  • Drago D. Inspections Panel, Annual Meeting of the Association of Food and Drug Officials, Huston, TX, June 19, 2017.
  • Drago D. Regulatory Communication Workshop, Annual Meeting of the Association of Food and Drug Officials, Huston, TX, June 18, 2017.
  • Drago D. Senatore F., Haire D., Mandernach S. How to Prepare and Conduct a Successful Meeting with Health Authorities, GW/ECPM Summer Institute Issues and Trends in Regulatory Science, Washington, DC, May 22, 2017.
  • Drago D. Weichold F., DeSantis T., Bull J., Butler J., Does Regulation Enhance or Hinder Innovation? GW/ECPM Summer Institute Issues and Trends in Regulatory Science, Washington, DC, May 22, 2017.
  • Drago D. Regulatory and Scientific Writing, GW/ECPM Summer Institute Issues and Trends in Regulatory Science, Washington, DC, May 24, 2017.
  • Drago D., Yocher R., Racic A., McIntyre R. FDA Inspections, GW/ECPM Summer Institute Issues and Trends in Regulatory Science, Washington, DC, May 24, 2017.
  • Phillips P., Rolih S., Drago D., Fant B. 510(k) – Who Needs One and What You Own When You Have One, FDA/Xavier MedCon, Cincinnati, May 4, 2017.
  • Drago D., Mollet A. Regulatory Writing, European Center of Pharmaceutical Medicine, Basel, Switzerland, February 7, 2017.
  • Drago D. Biologics and Biosimilars, Graduate Health Policy Class at the Milken Institute School of Public Health (PUBH 6374), George Washington University, Washington, DC, December 8, 2016.
  • Drago D. Professionalism Storyboard, AFDO SME Meeting, Orlando, FL, December 2, 2016.
  • Drago D. An Eight-Step Guide To Developing Your First Healthcare Product, GW Biotech Club Professors Speakers Series, George Washington University, Washington, DC, November 10, 2016.
  • Drago D., Singer N. Regulatory Writing Toolkit, Regulatory Affairs Professional Society, Rockville, MD, October 20, 2016.
  • Drago D. Handling Regulatory Challenges, 2016 RAPS: The Regulatory Convergence, San Jose, CA, September 19, 2016.
  • Yocher R., Drago D., Morton M., Singer N. Critical Thinking Skills for Regulatory Professionals, 2016 RAPS: The Regulatory Convergence, San Jose, CA, September 20, 2016.
  • Bowen L., Drago D. Conversations That Matter, 2016 RAPS: The Regulatory Convergence, San Jose, CA, September 20, 2016.
  • Drago D. Food and Drug Administration Approval Processes, GLG Series, July 19, 2016.
  • Drago D. Regulatory Writing: A Tool Kit, GW/ECPM Summer Institute Issues and Trends in Regulatory Science, Washington, DC, July 13, 2016.
  • Drago D. Yocher R., Racic A. The Secrets to Effectively Handling FDA Inspections, GW/ECPM Summer Institute Issues and Trends in Regulatory Science, Washington, DC, July 13, 2016.
  • Drago D., Morton M., Milstein J. How to Prepare and Conduct a Successful Meeting with Health Authorities, GW/ECPM Summer Institute Issues and Trends in Regulatory Science, Washington, DC, July 11, 2016.
  • Drago D. From Prof-of-concept to Market: A Regulatory Perspective, EMPA – Swiss Federal Laboratories for Materials Science, Dübendorf, June 30, 2016.
  • Drago D. Bringing Healthcare Products from the Bench to the Bedside: How a Few Make it and Why Many Don’t, University of Bern, Switzerland, June 28, 2016.
  • Drago D. Good Documentation Practices, Abbott Diabetes Care, Witney, UK, June 15, 2016.
  • Drago D., Roenninger, S. US Regulations and Enforcement Systems, ETH CAS Pharmaceuticals – from Research to Market, Quality and GMP, Zurich, Switzerland, June 8, 2016.
  • Drago D. FDA Warning Letters, ETH CAS Pharmaceuticals – from Research to Market, Quality and GMP, Zurich, Switzerland, June 8, 2016.
  • Drago D., Singer N. 483 Response: Common Pitfalls And How To Avoid Them, Implants 2016 Conference, RMS Foundation, Interlaken, Switzerland, April 26, 2016.
  • Drago D. Healthcare Products: How A Few Make It To The Market And Why Many Don’t, 2016 Seminars on Drug Discovery and Development, ETH Zurich, Switzerland, March 9, 2016.
  • Drago D. The Chemistry Of Your Documents, 2016 PhD Workshops, University of Torino, Italy, March 4, 2016.
  • Drago D. Handling Regulatory Challenges: How To Respond With Grace Under Pressure, 2015 RAPS: The Regulatory Convergence, Baltimore, MD, October 26, 2015.
  • Bonnin E., Pack R. Math C., Drago D. Food And Drug Administration’s Baltimore District Office: A Panel Discussion, 2015 RAPS: The Regulatory Convergence, Baltimore, MD, October 27, 2015.
  • Drago D., Shire S., Ekmekci O. Improving Regulatory Education: Can We Reconcile Employers’ Expectations With Academic Offerings? AGRE Annual Meeting, Baltimore, USA, October 25, 2015.
  • Drago D. From The Bench To The Bedside: An Overview Of The Drug Development Process In The US, GLG Summer Series, July 14, 2015.
  • Drago D. Shaping Your Regulatory Career – If I Only Knew Then What I Know Now. 2014 RAPS: The Regulatory Convergence, San Diego, USA, September 29, 2014.
  • Drago D. Biosimilars: Opportunities And Challenges, Pharmaceutical Policy Class at the School of Public Health and Health Services, George Washington University, Washington DC, USA, September 2014.
  • Drago D. Working In Regulatory Affairs: A Tale From Industry To Academia. East Coast Regional Career Day, Rockville, USA, May 17, 2014.
  • Drago D., Singer N., Chambleee A. Effective Regulatory Communication, Graduate Regulatory Science Class, Johns Hopkins University, Rockville, USA, April 22, 2014.
  • Drago D. A Global Regulatory Perspective On Biosimilars, Residency Fellowship in Health Policy- School of Public Health and Health Services, Washington DC, USA, March 25, 2014.
  • Drago D. Taking Your Career To The Next Level, Regulatory Affairs Professional Society National Webcast, Regulatory Affairs Professional Society, February 6, 2014.
  • Drago D. Global Regulatory CMC and the Change Control Process, Bausch and Lomb Aubenas, France, April 18, 2012.
  • Drago D., Obeng K., Chemistry, Manufacturing, and Control Regulatory Strategies – A primer, Bausch and Lomb Aubenas, France, April 18, 2012.
  • Drago D. Medizinische Einführung: Schmerzen, Halsschmerzen und deren Behandlung, Reckitt Benkiser (Switzerland) AG, Vienna, Austria, April 13, 2011.
  • Drago D. Pharmakovigilanz, Qualitätsmängel, Cosmetioviglance, und Materiovigilance, Reckitt Benkiser (Switzerland) AG, Zürich, Switzerland, March 23, 2011.
  • Drago D. Pain in Childhood: Treatment or No Treatment, Northern Europe Regulatory, Medical and Commercial Annual Best Practice Meeting, Reckitt Benkiser Ltd. London, UK, July 2011.
  • Drago D. Engaging with Key Opinion Leaders: An Opportunity You Shouldn’t Miss, Northern Europe Regulatory and Medical Annual Best Practice Meeting, Reckitt Benkiser Ltd. London, UK, July 2011.
  • Drago D. PIP Pediatric Investigation Plan, Global Regulatory Affairs Annual Meeting, Vifor Pharma Ltd, Zurich, Switzerland, September 2009.

Contact Daniela Drago, Ph.D.

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