From Molecule to Market: R&D And Regulatory Considerations builds on the business overview of the Intro to Business course. This course delivers an outline of clinical, regulatory, and quality considerations and practices. Attendees will be provided foundational information about the Biopharma industry and regulations via instruction, storytelling, and breakout group discussions. Applied industry ethics will be discussed with emphasis on historical precedents. The course will explore the decision-making process by touching on relevant topics such as market share and phases of development.

Schedule

1. Monday, May 15th, 2023, 10:00 AM – 12:30 PM EST
2. Tuesday, May 16th, 2023, 10:00 AM – 12:30 PM EST
3. Thursday, May 18th, 2023, 10:00 PM – 12:30 PM EST

Agenda

Session 1:

• The History of Regulations
• Industry Overview
• Research & Development: An Overview of R&D

Session 2:

• Roles in Clinical Trials
• Marketing Considerations

Session 3:

• Compliance via Regulatory & Quality Processes

Instructor

Nazma M. Rosado, MAOL, PMP, CMQ/OE
President & Principal, Avion Consulting

Nazma Rosado, a Principal at Avion 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.