Business of Biotech 201: From Molecule to Market, R&D and Regulatory Considerations (April 2021)
If you are registered for Business of Biotech 101 or have taken the course in the past year, you are eligible to receive a 10% discount applied to your registration of Business of Biotech 201. Contact firstname.lastname@example.org to obtain the coupon code to enter when checking out.
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.
- Monday, April 5th, 2021 03:00 PM - 05:30 PM EST
- Wednesday, April 7th, 2021 03:00 PM - 05:30 PM EST
- Friday, April 9th, 2021 03:00 PM - 05:30 PM EST
The History of Regulations
Research & Development: An Overview of R&D
Roles in Clinical Trials
Compliance via Regulatory & Quality Processes
Nazma M. Rosado, MAOL, PMP, CMQ/OE
President & Principal, Transformative Consulting
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. Nazma was involved with TransCelerate Biopharma, Inc. for 2 years and served as a Co-Lead for the Change Management Council and as the Change Champion for Astellas Pharma. She also served as a member of the Healthcare Businesswoman’s Association (HBA) Mid-Atlantic Region board (Programming Co-Chair). Nazma currently serves on the Board of the Organization Development Network and is the Chair of the Marketing & Communications Committee.
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