Loading…
Type: 15: Content-Hubs clear filter
arrow_back View All Dates
Monday, June 16
 

12:10pm EDT

#115 CH: Leading Teams Through Organizational Change and Layoffs: Best Practices for Change Management
Monday June 16, 2025 12:10pm - 12:40pm EDT
L Street Bridge
Component Type: Workshop
Level: Advanced

Learn best practices for leading teams through change and layoffs with confidence and empathy. Gain strategies to communicate effectively, maintain morale, and ensure business continuity. Leave with actionable insights to navigate transition.

Learning Objectives

Identify key change management strategies to lead teams effectively through organizational change and layoffs; Demonstrate effective communication techniques to maintain trust, morale, and engagement during transitions; Develop action plans to support employees, minimize disruption, and ensure business continuity.

Chair

Vidya Narayanaswamy, MBA, MSc

Speakers
avatar for Vidya Narayanaswamy

Vidya Narayanaswamy

Senior Consultant, IPM, United States
Vidya Narayanaswamy is a Senior Consultant at IPM, bringing over 12 years of experience across the life sciences industry—from early development through late-stage programs and global regulatory submissions. She holds an MS in Biotechnology and an MBA with a focus on Leadership... Read More →
Monday June 16, 2025 12:10pm - 12:40pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   07: ProjectManagement-StrategicPlanning, Workshop

1:30pm EDT

#119 CH: Development of Regulatory Strategies for Global Evaluation of Post Approval Changes and Lifecycle Management of Drug Products
Monday June 16, 2025 1:30pm - 2:30pm EDT
L Street Bridge
Component Type: Workshop
Level: Advanced

Post-approval changes are inevitable throughout a drug product's life cycle. Due to the complex regulations in ROW countries (the rest of the world), approval of these post-approval changes usually takes several years globally.

Learning Objectives

Recognize the importance of post-approval changes in a product life cycle; Analyze the complexity of implementing post-approval changes and its impact on the commercial drug product supply; Propose the key requirements to take steps industry-wide to solve A global problem needs a global solution.

Chair

Ana Sengupta, MBA, MS, RAC

Speakers
avatar for Ana Sengupta

Ana Sengupta

Director Regulatory Affairs CMC, Mirum Pharmaceuticals, Inc., United States
Ana Sengupta, Director in Regulatory Affairs at Mirum Pharmaceuticals, Inc. She has more than 25 years of pharmaceutical industry experience and 15 years of direct experience in global regulatory affairs of drugs and biologics. Before working at Mirum Pharmaceuticals, she worked in... Read More →
Monday June 16, 2025 1:30pm - 2:30pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   10: RegCMC-Product Quality, Workshop
 
  • Filter By Date
    Jun 9 - 19, 2025
    June 2025
    SunMonTueWedThuFriSat
    1234567
    891011121314
    15161718192021
    22232425262728
    2930 
  • Filter By Venue
    Washington, D.C., USA
    All
    143ABC
    144ABC
    145AB
    146ABC
    146BC
    147AB
    150AB
    151A
    151B
    152AB
    201
    202A
    204ABC
    206
    207A
    207B
    209ABC
    Ballroom
    Ballroom Foyer 3rd Floor
    EH
    Exhibit Hall / Zone A
    Exhibit Hall / Zone B
    Exhibit Hall / Zone C
    Exhibit Hall Lunch
    Innovation Theater 1
    Innovation Theater 2
    Innovation Theater 3
    L Street Bridge
    Nationals Park
    Planet Word
    Room 145-147 Lobby
    Salon B
    Salon C
    TBD
    Virtual
    West Salon
  • Filter By Type
    00: Plenary
    All
    Forum
    01: ClinSafety-PV
    All
    Forum
    Session
    02: ClinTrials-Ops
    All
    Forum
    Session
    Tutorial
    Workshop
    03: Data-Tech
    All
    Forum
    Session
    Tutorial
    Workshop
    04: MedAffairs-SciComm
    All
    Forum
    Session
    05: Patient-Impact-Product-Dev
    All
    Forum
    Session
    06: PersonalizedMed-ComboProd-Diagnostics
    All
    Forum
    Session
    Tutorial
    07: ProjectManagement-StrategicPlanning
    All
    Forum
    Session
    Tutorial
    Workshop
    08: RD-Quality-Compliance
    All
    Forum
    Session
    Tutorial
    09: Regulatory
    All
    Forum
    Session
    Tutorial
    Workshop
    10: RegCMC-Product Quality
    All
    Forum
    Session
    Tutorial
    Workshop
    11: Statistics-Data Science
    All
    Forum
    Session
    Tutorial
    12: ProfDevelopment
    All
    Forum
    Session
    Tutorial
    Workshop
    13: Spotlight
    All
    Forum
    Session
    14: DIAmond
    All
    Forum
    Session
    15: Content-Hubs
    All
    Workshop
    16: Community-Rounds
    All
    Session
    Workshop
    17: Posters
    All
    Session
    18: InnovationTheaters
    All
    Session
    19: Networking-Opportunities
    All
    Session
    Social Event
    20: Short-Courses
    All
    Tutorial
  • Level
    Advanced
    Basic
    Intermediate
  • Keyword
    Advanced Analytics
    Artificial Intelligence (AI)
    Bioethics
    Biomarkers
    Cell and Gene Therapy
    Clinical Trial Design
    Diagnostics
    Digital Technology
    Global Perspectives
    Non-CE
    Patient Experience
    Payers
    Pediatrics
    Rare Disease
    Real-World Data (RWD) / Real-World Evidence (RWE)
    Regulator Perspectives
    Regulatory Collaboration
    Regulatory Convergence and Harmonization
    Regulatory Reliance
    Student Programming
  • Timezone
Need help? View Support Guides
Event questions? Contact Event Planner
Powered by Sched Event Planning App
©2025 Sched • About • Privacy • Terms
Share Modal

Share this link via

Or copy link

Filter sessions
Apply filters to sessions.
Filtered by Date - 
Clear filter
Monday, June 9
Tuesday, June 10
Wednesday, June 11
Thursday, June 12
Sunday, June 15
Monday, June 16
Tuesday, June 17
Wednesday, June 18
Thursday, June 19
143ABC
144ABC
145AB
146ABC
146BC
147AB
150AB
151A
151B
152AB
201
202A
204ABC
206
207A
207B
209ABC
Ballroom
Ballroom Foyer 3rd Floor
EH
Exhibit Hall / Zone A
Exhibit Hall / Zone B
Exhibit Hall / Zone C
Exhibit Hall Lunch
Innovation Theater 1
Innovation Theater 2
Innovation Theater 3
L Street Bridge
Nationals Park
Planet Word
Room 145-147 Lobby
Salon B
Salon C
TBD
Virtual
West Salon
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD-Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: ProfDevelopment
  • 13: Spotlight
  • 14: DIAmond
  • 15: Content-Hubs
  • 16: Community-Rounds
  • 17: Posters
  • 18: InnovationTheaters
  • 19: Networking-Opportunities
  • 20: Short-Courses
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Keyword
  • Advanced Analytics
  • Artificial Intelligence (AI)
  • Bioethics
  • Biomarkers
  • Cell and Gene Therapy
  • Clinical Trial Design
  • Diagnostics
  • Digital Technology
  • Global Perspectives
  • Non-CE
  • Patient Experience
  • Payers
  • Pediatrics
  • Rare Disease
  • Real-World Data (RWD) / Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Convergence and Harmonization
  • Regulatory Reliance
  • Student Programming