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08:50 - Chairperson opening remarks
BEN LOCWIN, VP, Project Solutions, Black Diamond Networks
09:00 – Pharmacovigilance Quality Assurance (QA)/Quality Control (QC) Synergy Identification and Simplification
ABBEY GOW, QA & Deviation Management Expert, Sanofi
09:30 – PV Ecosystem is continuously evolving- Combination Products and now Diagnostics and Digital
• How do we as an industry partner with the Regulatory bodies and agencies to share our voice
• People / Processes and Technology – as enablers to maintain the patient-centric approach
• How do we truly ensure that safety is our priority – regardless of its source – Drug, Device, Diagnostic or Digital therapeutics
KHAUDEJA BANO, VP - Global Head of Device Quality, Roche - Genentech
10:00 – Keynote Panel Discussion: Next generation pharmacovigilance for enhanced patient safety
• Driving patient centricity into your PV plans
• Patient Support Program in Pharmacovigilance
• A review of general issues and the specific challenges with patients
• Improving your organization’s patient-facing communications and its importance
• A practical approach to reshaping patient safety
• Educating stakeholders via patient stories
Moderator
MARIETTE BOERSTOEL-STREEFLAND, SVP, Worldwide Patient Safety Officer, Bristol-Myers Squibb
Panellists
KHAUDEJA BANO, VP - Global Head of Device Quality, Roche – Genentech
KARTHIK MUTHUSAMI, Head of Expedited Safety Reporting, Bristol-Myers Squibb
KARTHIK BABU, CHC Global PV Operations Head, Sanofi
10:40 – Morning Networking Coffee/Tea & Discussion
11:10 – Topic TBC
Speaker TBC, Cencora
11:40 - Pharmacovigilance Compliance for future – Moving forward positively
• Future horizons and efficiencies in PV Compliance
• Managing quality risks
• Fostering culture of inspection readiness preparing for, inspections
• Future-proofing organizations
• Boldly Shaping the Future
JESSICA CHINAULT-JALBOOT, Exec Dir, Regulatory and PV Compliance, Jazz Pharmaceuticals
KSHITIJA BAPAT, Dir, Compliance Operations, Jazz Pharmaceuticals
12:10 – Harnessing GenAI to Advance Pharmacovigilance
• Explore the expansive potential of GenAI in transforming pharmacovigilance, including ArisGlobal's approach to future capabilities and uncertainty.
• Discover the in-market extraction and generation capabilities of LifeSphere NavaX and learn how these capabilities are being developed to enhance performance.
• Get insights into the dawn of Agentic AI and its potential as the next positive disruptor for automation.
• Learn about ArisGlobal's commitment to responsible AI practices, addressing the challenge of AI hallucinations and the imperative for collaborative regulatory engagement.
JASON BRYANT, VP Data & AI, ArisGlobal
12:40 – Networking luncheon
13:30 – Panel Discussion - Technology: Unlocking the better ways in PV for safer drugs
• Acceleration of Digitalisation in Pharma is the key to innovation in Pharmacovigilance
• How long can AI, process automation and improvements give a hand in PV?
• ML in patient monitoring: How do industrial experts see this?
• Regulatory decision – Making: In what way AI makes the path easier?
• Modern technologies in pharmacovigilance - The way foward
• Signal detection and safety data analysis
• Implementation Challenges - Preparing for a smooth transition
• Pitfall and Learnings
Moderator
HEATHER LEIGH FLANNERY, CEO & Co-Founder, AI MINDSystems Foundation
Panellists
E. ALTON SARTOR, Medical Director, Patient Safety Physician Digital & Devices, AstraZeneca
BEENA WOOD, Head of Innovation & Technology, CSL Behring
RAM VEMPATI, Medical Director, BioNTech SE
MATT DORMARUNNO,Head, Global Safety Sciences, CSL Behring
YILONG JIA, Sr. Manager Pharmacovigilance Informatics, Sumitomo Pharma America
14:20 – Topic TBC
Speaker TBC, Veeva Systems
14:50 – Managing Pharmacovigilance Audits & Inspections
• Staying ahead in the race - Current trends for and future guidelines
• How to prepare and what to expect?
• Remote audits and inspections - Logistical issues
• PV Inspection readiness: Keeping on the right side of inspectors
• Methodologies, scope and oversight
• Boldly shaping the future
• What has this pandemic thought us towards audits and inspections?
KAPIL BHUTADA, Head of PV Safety Operation & Compliance, Asklepios BioPharmaceutical
15:10 - Afternoon Networking Coffee/Tea & Discussion
15:30 - Quality, Safety Evaluation & Signal Detection – Important Considerations - Analise to Adapt
• Developing a global safety intelligence process
• Exploring patient support and marketing research programs from a safety perspective
• Develop an aggregate safety assessment planning (ASAP) process – Its importance
• Expectations for quality and compliance in pharmacovigilance process and systems
• What is now essential for both good quality management and to drive continuous improvement?
• Statistical signal detection as a routine pharmacovigilance practice
15:50 – AI in Pharmacovigilance: Streamlining Local and Global Literature Surveillance
• The challenges of Local Literature in Pharmacovigilance
• How AI is Transforming Literature Surveillance
• Biologit’s AI Approach
• Regulatory Considerations and AI Adoption
NICOLE BAKER, CEO, Biologit
16:10 – Panel Discussion: Navigating the challenges with a global PV
• What comes next for the industry?
• Challenges of Global PV function in a changing business environment
• Automating pharmacovigilance: Are we ready for the up coming future?
• How global PV impacts day to day operations?
• Proper communication between - Sponsor – Site – CRO – Patients
• Moving towards a better future: bigger and better
• Best practices & lessons learnt today
Moderator
ANKA EHRHARDT, Director, Cell-Based Assays / Analytical Research &, Development, Merck
Panellists
NINA KOLA, VP, Head Medical Safety Assessment Hematology and Oncology, Bristol-Myers Squibb
MILIND SARDESA, Senior Director, Safety Surveillance, Global Patient Safety, Novo Nordisk
KSHITIJA BAPAT, Dir, Compliance Operations, Jazz Pharmaceuticals
VIKALP KHARE, Director, Otsuka Pharmaceutical
17:00 – Closing remarks by chairperson and End of day 01 conference
17:10 – 18:15 – Networking Drinks
09:00 - Chairperson opening remarks
BEN LOCWIN, VP, Project Solutions, Black Diamond Networks
09:10 – Behind Every Successful Drug also Stands an Excellent CMC
ANKA EHRHARDT, Director, Cell-Based Assays / Analytical Research & Development, Merck
09:40 – Pharmacovigilance’s Exponential Technology Upgrade: the Emerging Role of the Patient, their Personal AI Agents, and their Personal Digital Twins
• Personal data estates, personal AI agents, and personal digital twins: understanding the fast-approaching, radically-enhanced role of the patient in PV
• PV and beyond: newly-empowered patients’ relationships to next-generation, pre-competitive industry utilities for pan-stakeholder, privacy-preserving, decentralized data and AI
• Verifications, attestations, and audits on-demand: multi-directional, cryptographically-provable reporting and communications from multiple provider institutions and patients directly
• From clinical trials to post-market surveillance to label expansion: accelerating the flywheel of increasing both safety and precision through in silico research and simulations
HEATHER LEIGH FLANNERY, CEO & Co-Founder, AI MINDSystems Foundation
10:10 – Topic TBC
Speaker TBC
10:40 – Morning Networking Coffee/Tea & Discussion
11:10 – Real World Data to Real World Evidence
• Importance of real-world data for answering regulatory questions
• Benefits and challenges of evidence derived from real world sources
• Real World Evidence: How Does its Use challenge quality and compliance programs?
• Obtaining patient-centric using RWE
• What are complications that will rise by inserting new data source? Breakup in data?
• Identify the challenges involved in incorporating real world evidence into a structured benefit-risk assessment.
WILLIAM A. BLUMENTALS, Head of Pharmacoepidemiology, Specialty Care, Sanofi
11:40 – How to build and present a Data Story with then Analytical Ask hierarchy: NLP based PV perspective
MEERA NAGARIA, Senior Data Scientist, Johnson & Johnson
12:10 – PV Audits in the USA
• The need for PV audits
• Types of PV audits
• Overview of thePV audit process
• Audit Challenges/Opportunities
• Common PV Audit Findings
HEATHER MURPHY, Founder and CEO, HMGlobal Pharmacovigilance Consulting
12:30 – Networking luncheon
13:30 – Panel Discussion - The “Next Generation” risk man agement strategies
• Implementation and maintenance of RMP’s – Overcoming its challenges
• Potential analyzing of safety and risk signals in PV
• Strategies to minimize the risk measures – what are the new developments?
• Benefit/Risk ratio: the common Denominator FDA REMA Logic Model
• Risk Evaluation and Mitigation Strategies (REMS) – new challenges and chances
• Stakeholders in REMS – Communications must be improved
• Implementing a Risk-Based Monitoring Solution: Understanding the basics of a ssustainable model
• Discussing about the strategies that support the PV from beginning to end
Moderator
DANYTZA WARD, Executive Director, Head of PV Operations & Global Risk Management, Jazz Pharmaceuticals
Panellists
CARMIT STRAUSS, Executive Director, Head of Risk Management and Organ Toxicity, Takeda Pharmaceuticals
SHARON REID, Director of Risk Management Center of Excellence, Pfizer
SIVA KUMAR BUDDHA, Director - PV (Head of Signal & Risk Management), Indegene
REEM YASIN, Quality Assurance & PV Manager, Kawkab group (Iraq)
14:20 – Panel Discussion: Key regulatory updates that can impact the PV to increase patient’s safety
• Current and future trends in PV regulations - A Step forward
• Balancing the critical elements of speed and safety
• Guidelines for critical medicines
• Future Legislation: PV Industry Vision
• Enhancing communication between regulators, regional authorities and patients
• Examine the global regulatory landscape for safety evaluation – Lessons to learn
• What’s next? Ways to proceed forward.
Moderator
BEN LOCWIN, VP, Project Solutions, Black Diamond Networks
Panellists
JESSICA CHINAULT-JALBOOT, Exec Director, Regulatory and PV Compliance, Jazz Pharmaceuticals
ASHISH JAIN, Sr, Director, Clinical Safety & Pharmacovigilance, Curis
15:00 - Afternoon Networking Tea/Coffee & End of conference
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ArisGlobals LifeSphere Safety offers the only unified, next-generation SaaS Safety platform in production, built to enable touchless case processing, scalable compliance, and standardized global pharmacovigilance workflows. Drive transformative change with industry-leading capabilities, including the latest innovations in automation, analytics, and GenAI technologies powered by LifeSphere NavaX.
Visit our website: www.arisglobal.com
PharmaLex is now part of Cencora, a leading global pharmaceutical solutions organization centered on improving lives around the world.
PharmaLex adds to Cencora’s expanding suite of pharma solutions and serves the pharma, biotech, and medtech industries. We guide clients from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology-elevated solutions to support clients through the entire product lifecycle.
Visit our website: www.pharmalex.com
Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,100 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves.
Visit our website: www.veeva.com
HMGlobal Pharmacovigilance Consulting offers comprehensive Pharmacovigilance consulting services tailored to companies at all stages of the product lifecycle. Whether you are a startup, a mid-sized company, or a large pharmaceutical or biotechnology organization, our team of experienced consultants can provide purpose-fit solutions to meet your specific Pharmacovigilance needs.
With our expertise in Pharmacovigilance regulations, best practices, and industry standards, we can help you establish and optimize your PV operations, ensure compliance with local and global regulations, implement robust quality assurance and compliance programs, develop and update SOPs and work instructions, manage safety database operations, conduct PV audits and mock inspections, and provide training to your staff.
Our goal is to provide strategic, compliant, and effective solutions that align with your company's unique requirements and business objectives. Contact us today to discuss your Pharmacovigilance needs and learn how HMGlobal Pharmacovigilance Consulting can support your organization in achieving operational excellence and regulatory compliance.
Visit our website: www.hmgpvconsulting.com
Biologit is an innovative technology leader in the pharmacovigilance (PV) industry. Led by a team of PV and engineering experts, Biologit has developed technology to transform the process of literature monitoring.
The biologit MLM-AI platform is a scientific literature monitoring platform for safety surveillance that is simple to use, fully web-enabled and powered by AI. biologit MLM-AI is a validated platform built following best industry practices and ready for your regulatory needs: the feature set fully meets GVP-VI guidelines for medical literature monitoring, and role-based user management and audit trail features to ensure CFR-11 compliance. Key features include Dashboards, Automated Reporting Functionality, E2B R3 Exporting Capability, EMA MLM Reviews and Integrated Machine Translation for both abstracts and full text.
The biologit MLM-AI platform is powered by the biologit Database: a comprehensive and continuously updated repository of scientific literature, ready for compliant regulatory searches, integrating databases of global and regional reach into an easy-to-use interface. The biologit Database contains over 110,000 journals representing over 165 countries, suitable for global and local literature searches for PV.
Biologit’s latest product, biologit for Local Medical Literature Monitoring, is designed to fully automate the local literature process, including unstructured sources like websites and print journals. This innovation provides customers with in-built translation capabilities, country-level filtering and country-level workflow features.
Trusted by top pharmaceutical companies, emerging biopharma, clinical research organizations and service providers, Biologit is committed to delivering exceptional value through innovation, compliance, and quality.
Visit our website: www.biologit.com
4C Pharma Solutions is established and operated by Physicians and Subject Matter Experts experienced in Clinical Research, Pharmacovigilance and Regulatory Affairs. It is one of the fastest growing global service provider organizations headquartered in the United States. The service spectrum spans Pharmacovigilance/Drug Safety, Devices, Biologics, Consumer Care products, Nutraceuticals & Cannabis products, Regulatory Affairs, Medical Writing, Argus Safety Database Hosting, Maintenance, Support and Training.
4C is focused on delivering quality services at an optimized cost to suit clients’ budget. We are ISO 9001 and 27001 certified with fully validated in-house Oracle Argus Safety installed on cloud for quick deployment and high availability. We provide quality support for Argus at drastically reduced costs facilitating companies to focus on R&D and other tasks without extensive technology overheads.
We have an exemplary team of healthcare and IT professionals, well-established facilities, processes and systems capable of providing end to end support in Dossiers (CTD/eCTD/NeeS) preparation, publishing, validation, submissions, Labeling, Artworks, Medical Information Call Center, Literature Search, Case Processing, Signal Detection, Aggregate Reports, Risk Management Plans, Pharmacovigilance SOPs preparation, System setup and Training. 4C team also has expertise on multiple safety and regulatory applications to accommodate any requirement.
Visit our website: www.4cpharma.com
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