From Molecule to Market: R&D and Regulatory Considerations

November 30, 2020 1:00 PM - December 4, 2020 3:30 PM

Online Course, Link will be sent in advance of the event.

Add to Calendar 11/30/2020 1:00:04 PM 12/4/2020 3:30:04 PM From Molecule to Market: R&D and Regulatory Considerations

This MassBioEd online course builds on the business overview of “The Business of Biotech 101” course. For those considering careers in the biopharma space or transitioning from the science and technical aspects of the industry, this course delivers an outline of Clinical, Regulatory, and Quality considerations and practices. Students will be provided foundational information about the BioPharma industry and regulations via instruction, storytelling, and breakout group discussions. Industry ethics will be discussed, with emphasis on historical precedents. We will explore the decision-making process by touching on relevant topics such as market share and phases of development.

Guest speakers will be invited to represent specific considerations and to showcase their roles and experiences. We will review Research and Development processes and considerations from pre-clinical through market approval.

Course Schedule:

  • Monday, November 30th, 2020, 1:00 PM - 03:30 PM
  • Wednesday, December 2nd, 2020, 1:00 PM - 03:30 PM
  • Friday, December 4th, 2020, 1:00 PM - 03:30 PM

 
Online Course, Link will be sent in advance of the event.
President & Principal Consultant
Nazma Rosado, President & Principal at Transformative Consulting, Inc. has over 25 years of experience in the Biopharma industry and has worked on phases I-IV with experience in all aspects of study management including study start-up, conduct and close- out. She has worked in Data Management, Clinical Operations, Regulatory Affairs and Quality Assurance, Project Management, Process Optimization, Learning & Development, Change Management, and, Organizational Design & Development for major and mid-sized pharmaceutical and small biotech companies, as well as for a contract research organization (CRO), and consulting companies. She has worked in a highly regulated industry and understands compliance needs. Nazma has focused on the Organizational Leadership and Development aspects of the companies she has worked for, and has been instrumental in designing and implementing solutions to better the workplace for staff and management. She works with senior leaders to help change behaviors that shape the company’s culture and increase employee engagement. Nazma has a passion for people and a strong desire to make the workplace more diverse, engaging, and productive by choice. Nazma has a B.A. in Neuroscience and a B.A. in Psychology from Colgate University and a M.A. in Organizational Leadership from Gonzaga University. She has 33 credits towards her Master in Public Health at the University of Connecticut. In addition to her traditional education, Nazma has earned many professional certifications including the following: Project Management Professional (PMP), Six Sigma Green Belt (6σ), Certified Professional in Learning & Performance (CPLP) and Certified Manager of Quality/ Organizational Excellence (CMQ/OE). She holds many certifications in Change Management as well including AMPG and Prosci certifications.