Speaker Profile


Robert Michalik

Founder & Principal Consultant, RegulatoryPro, LLC

Robert Michalik J.D, RAC, is a Massachusetts regulatory attorney and founder of RegulatoryPro.com, a consulting firm providing general and specialized services to the biopharmaceutical and medical device industries. Mr. Michalik has over 25 years’ experience working in the biopharmaceutical and medical device industries. Starting with a bachelor’s degree in science (biochemistry), Bob has held a wide variety of technical, quality and regulatory positions that literally span the scope of new product development and commercialization activities. Mr. Michalik is former faculty member with Northeastern University (Boston, MA) Master’s Program in FDA Regulatory Affairs

  •  Wednesday, June 6, 2018
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • ¤150.00
Advanced Legal Writing Methodologies for Successful FDA 'Breakthrough Therapy' Submissions

The scientific and regulatory landscapes continue to evolve as novel breakthrough therapies are envisioned and developed in R&D labs around the world. Gene editing via CRISPR and nuclease enzymes such as Cas9, Cpf1 or C2c1, PAM-dependent target recognition, and gene delivery approaches such as adeno associated virus (AAV) are dominating the news today.

  •  Thursday, June 28, 2018
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • ¤150.00
Chemistry 101 for Medical Device Regulatory & Quality Professionals: Essential knowledge needed to Manage Drug&Device Combination Product Project

Medical device regulatory and quality professionals are often responsible for overseeing the development of combination products that include small or large drug "active pharmaceutical ingredients" to achieve the clinical therapeutic effect.

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  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤190.00
FDA - Legal Writing Skills that Result in Effective Regulatory Submissions

Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on complex scientific and technical arguments.

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤190.00
FDA - Legal Writing Skills that Result in Effective Regulatory Submissions

Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on complex scientific and technical arguments.

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤190.00
FDA - Legal Writing Skills that Result in Effective Regulatory Submissions

Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on complex scientific and technical arguments.

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤190.00
Chemistry 101 for Medical Device Regulatory & Quality Professionals: Essential knowledge needed to Manage Drug&Device Combination Product Project

Medical device regulatory and quality professionals are often responsible for overseeing the development of combination products that include small or large drug "active pharmaceutical ingredients" to achieve the clinical therapeutic effect.

View All

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