STATE OF PHARMA
Quality | Regulatory | Clinical | Pharmacovigilance
State of Pharma brings together speakers with a wealth of expertise and experience across a number of different aspects important to the pharmaceutical industry, focusing on key areas that includes quality assurance, regulatory compliance, clinical research and pharmacovigilance.
As the global pharmaceutical industry continues to move forward at a rapid pace, the tools, skills and knowledge of experts and organisational leaders are needed for the industry to thrive. You will hear from these experts and our exclusive speaker lineup of highly sought-after industry professionals.
The conference provides a premier interdisciplinary platform for researchers, practitioners, and representatives from governing bodies to present and discuss the most recent innovations, trends, concerns and practical challenges impacting the pharmaceutical industry at this very moment and will provide details on how to overcome these challenges as it relates to the drug development and manufacturing sectors.
EVENT FEATURES
- In-depth discussions on a wide range of topics related to the pharmaceutical industry
- Technical knowledge and expertise from industry leaders and representatives from regulatory bodies addressing currently challenges and potential solutions
- Virtual conference that can be accessed anywhere in the world
- Two-track approach allowing flexible attendance for only the speakers and talks you want to see
Expert Speakers
Our expert panelists consist of regulatory specialists, scientists, and business leaders
providing diverse perspectives on the pharmaceutical industry. Our aim is to deliver valuable educational content and networking opportunities for all attendees.
-
Laleh Bighash
AAPS
President and Dean of Scientific Affairs -
Amanda McFarland
ValSource, Inc.
Senior Consultant -
Heather Longden
Milford
Consultant -
Kenneth Christie
VTS Consultants, Inc.
Chief Operating Officer
Schedule
MAY 11th 2023
Regulatory Affairs
Lessons Learned from the Pandemic and Landscape Moving Forward
Regulatory Labelling Challenges
Recent Developments and Impact of the EU Legislative/Policy Environment
Recent Developments and Impact of the US Legislative/Policy Environment
Quality Assurance
Process Validation – Critical Process Validation
Critical Cleaning Validation
Conducting Remote GMP Inspections of API Manufacturers in Real Time
Utilization of a Quality Risk Management Approach
Strategies on Current Challenges in Data Integrity and Identifying Ways to Mitigate Risk
Human Error: Effectively Resolving the Most Common Cause of Quality Failures
Recently Published Guidance on cGMP and Quality
PV
Key Steps for Establishing and Maintaining Compliance with all Applicable Internal and External Requirements and Regulations
Pharmacovigilance Audit Inspection and Quality Systems
Global Considerations for Periodic Reports, Benefit Risk Management and Risk Minimization and the Lifecycle Implications
Post-Marketing Surveillance in Phamacovigilance
Clinical Research
Clinical Research in a Post-Pandemic World
How to Develop a Detailed Guideline for Systematic Site Selection
Clinical Trial Design and Alternative Data Sources (e.g. Diversity, real-world data, precision medicine and patient-focused drug development
How to Prepare for New Developments in the Study Feasibility Processes in 2023
How to Make Appropriate Protocols To Manage the Framework of Investigators’ Activities and Interactions
Our Sponsors
We are inviting a limited number of organizations to join as Sponsors of the event.
For more information or to express an interest please reach out to info@aaps.ca.
If you are interested in sponsorship opportunities at the State of Pharma conference, contact us today!