STATE OF PHARMA
Quality | Regulatory | Clinical | 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.
DATE:
May 11, 2023
TIME:
9AM – 5PM EST
GENERAL ADMISSION FEE:​
$99+Taxes
DATE:
EARLY BIRD AND GROUP DISCOUNTS AVAILABLE
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
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
Varun Venkatachalam
Consultant
NSF international
Martti Ahtola
Tepsivo
The chief Operating Officer
Adam Brown
ClinArk
Chief Executive Officer
Kim McDonald-Taylor
McDonald-Taylor Consulting
Consultant
Manar Hammood
Zenith PV Solutions Inc.
Founder & Director of PV Operations
SCHEDULE
MAY 11th 2023
- 9:00 – 9:15 AM
Welcome Remarks
- 9:15 – 10:00 AM
Developing a Tool Kit and Quality Mindset for Successful Quality Risk Management
Quality Risk Management (QRM) is a systematic process for the assessment, control, and communication and review of risks to quality of the drug product across the product lifecycle. Risk-based compliance is expected by regulatory agencies and strongly recommended by industry to balance compliance efforts and costs vs. product quality and patient safety. Amanda McFarland, a QRM and Microbiology Senior Consultant with ValSource, Inc., will discuss how to apply QRM principles and risk-based decision making consistently, how to use the suite of tools available to manage risk effectively, and how to ensure all levels of management buy-in to the program.
- 10:00 – 10:45 AM
Utilization of a Quality Risk Management Approach
Quality management maturity is the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement. While metrics and inspections / audits have been the mainstay for assessing a quality system’s effectiveness and maturity, these are probabilistic and atomistic in practice. A Quality Management Maturity assessment holistically assesses the health of a quality system and provides deep insights into the prevailing quality culture. This session will also discuss the recent efforts by the U.S. Food and Drug Administration (FDA) to secure drug supply chains with the piloting of CDERs QMM program.
- 10:45 – 11:30 AM
Strategies on Current Challenges in Data Integrity and Identifying Ways to Mitigate Risk
Data integrity is of the utmost importance in pharmaceutical manufacturing. Companies are expected to not only identify risk factors but also mitigate them. What tools do we have at our disposal? What technologies can help to improve our data quality? How often should we be performing maintenance on our system? This session will look specifically at how to maintain data integrity within a laboratory environment and discuss the best ways for organizations to stay ahead and identify, understand, and remediate concerns about paper or electronic forms, spreadsheets or documents used to record GMP data.
- 11:30 – 12:15 PM
Human Error: Effectively Resolving the Most Common Cause of Quality Failures
Analysis of investigation reports reveal that human error is one of the top root causes for deviations, discrepancies, and quality incidents in pharmaceutical manufacturing. This session will discuss regulatory requirements for detecting, correcting, and preventing human errors in manufacturing and laboratory environments as well as developing a competent, effective corrective and preventive action system. You will learn why human error is often designated as the root cause of deviations and discrepancies, identify why your CAPA’s are less effective than you hoped, understand why human error as opposed to deviations causes deficiencies and learn how to probe further to identify the causes or contributing factors that really cause the problems you are seeing.
- 12:15 – 1:00 PM
Lunch Break
- 1:00 – 1:45 PM
Key Considerations for establishing and maintaining compliant PV system and its role in post-market surveillance
Join Manar Hammood, the Founder & Director of PV Operations at Zenith PV Solutions Inc., as she discusses the key considerations for establishing and maintaining a compliant Pharmacovigilance (PV) system and its role in post-market surveillance.
In this session, key elements to be considered in the set-up and maintenance of a compliant PV system in accordance with Health Canada GVP guidelines will be discussed. Additionally, important aspects of post-market surveillance PV activities will be covered. Manar will share her insights and experiences gained from working in Senior Medical and Operations roles in the pharmaceutical industry. She will provide guidance on meeting Health Canada and other global regulatory compliance standards, as well as share best practices for setting up and maintaining a compliant PV system.
- 1:45 – 2:30 PM
Global Considerations for Periodic Reports, Benefit Risk Management and Risk Minimization and the Lifecycle Implications
Periodic reports, benefit risk management and risk minimization are essential components of pharmacovigilance that require careful planning and execution throughout. In this session, you will learn from Martti Ahtola, COO at Tepsivo, who will discuss the challenges and opportunities of working with different regulatory authorities, data sources and stakeholders across the lifecycle of a medicinal product.
Some of the topics that will be covered in this session include:
- How to prepare and submit periodic reports (PSURs, PBRERs, DSURs) to different regulatory authorities and what are the common pitfalls to avoid
- How to conduct benefit risk assessments and communicate them effectively to internal and external stakeholders
- How to design and implement risk minimization measures (RMMs) that are tailored to different regions and populations
- How to leverage data analytics, automation and artificial intelligence to streamline and optimize pharmacovigilance processes
- How to collaborate with other functions (e.g., clinical development, medical affairs, marketing) and external partners (e.g., health authorities, patient groups, healthcare professionals) in a global setting
- Martti will also present some examples of how Tepsivo uses innovative solutions to streamline and optimize these processes. He will share their best practices, tips and tricks, and innovative solutions to help you optimize your pharmacovigilance activities and ensure compliance with regulatory requirements.
- 2:30 – 3:15 PM
Clinical Research in a Post-Pandemic World
As the world continues to navigate the ongoing pandemic, it has become clear that the clinical research landscape has undergone rapid and unprecedented changes. To explore these changes and discuss the latest trends and advances in clinical research, we invite you to join us for an insightful session on clinical research in a post-pandemic world.
Our expert speaker, Kim McDonald-Taylor, MSc, CRPC, is an industry leader with extensive experience in project management, SOP creation/review, medical writing, teaching, meeting facilitation, and strategic planning. Kim will share her expertise in these areas and discuss how these practices have evolved in the new normal, including the use of decentralized CTs, remote monitoring, and Zoom meetings.
- 3:15 – 4:00 PM
Clinical Trial Design and Alternative Data Sources (e.g. Diversity, real-world data, precision medicine and patient-focused drug development
Clinical trials are essential for advancing medical knowledge and improving health outcomes. However, designing and conducting clinical trials can be challenging, especially when dealing with rare diseases, diverse populations, real-world data, precision medicine and patient-focused drug development. How can researchers overcome these challenges and optimize their trial design using alternative data sources? Join Adam Brown, Founder and CEO at ClinArk, as well as a researcher and community advocate with extensive experience in community-based participatory research approaches, as he shares his insights and best practices on this topic.
Adam will discuss:
- How to leverage different types of source documents.
- How to use hybrid trial methodology that combines traditional randomized controlled trials (RCTs) and observational study designs.
- How to apply alternative designs such as cross-over and n-of-1 trials, enriched enrollment, randomized withdrawal design, and adaptive designs.
Whether you are a novice or an expert in clinical trial design, you will benefit from this session that will help you enhance your evidence-based practice using real-world data.
- 4:00 – 4:15 PM
Closing Remarks
* Agenda and speakers are subject to change
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