Critical Updates To Keep Pace With The Practical Potential Of AI & Emerging Technologies, Identify New Risks In A Volatile Geopolitical Landscape & Navigate Constantly Changing Legislation To Develop
Proactive & Innovative Risk & Compliance Strategies Across Pharma & Life Sciences
08.15 Registration & Informal Networking
OPENING REMARKS
09.00 GIC Welcome & Morning Chair’s Opening Remarks
Alex Davison, Compliance Director Europe & Global Projects, Amarin
Geopolitics & International Risk
PANEL Q&A
09.10 Increase Your Proactivity & Agility In Navigating Uncertain Times By Effectively Preparing For Global Pharma Regulatory Developments In A Volatile Geopolitical Landscape
- From elections to conflict and tariffs to sanctions, discuss and debate how to monitor a rapidly changing and turbulent geopolitical landscape in order to anticipate the impact of operating a global business in a divided world
- Ensure operational continuity and ethical standards to remain steadfast in the face of potential instability and disruption
- Deep dive into the implications for your functions: not only remaining abreast of the global developments but navigating the potential consequences – or opportunities – for your operations to develop and evolve
- Proactivity not reactivity: craft agile frameworks and innovative ideas to effectively anticipate and respond to ever-changing circumstances
Lucy Sales, Senior Director – Risk & Compliance, AstraZeneca
Claire Crabtree, Senior Supplier Risk Manager, Roche
Anastasia Troyan, Senior Director Global Compliance & Ethics, Teva
Dr. Qintao Liu FRSC PhD MBA BSc, Director, Compliance Human Biological Samples, AstraZeneca
Gabor Sulyok, Global Head of Commercial and Healthcare Compliance, BioNTech
AI & Automation
09.40 Harness The Practical Potential Of AI & Master Regulatory Framework Development To Advance AI Adoption Across All Functions
- Move beyond discussing the theoretical implications of AI to discover best practices for effectively using AI to streamline operations and maximise efficiencies across all functions
- Navigate current and upcoming AI legislation to anticipate what the next regulatory updates may focus on, and ensure compliance through the adoption and implementation of AI strategies
- Monitor the regulatory challenges in digital therapeutics and AI-driven drug discovery, and ensure that AI usage complies with data security policies to advance AI usage while complying with regulatory requirements
- As the capabilities of AI continue to evolve and change, how can you develop and enforce robust, ethical and compliant AI policies to ensure its proper usage?
Alexis Pagé, Business Ethics Director, Ipsen
ABPI Regulatory Updates & Trends
10.00 Patients & Public Engagement: Health Information Landscape
- Gain an exclusive insight into the current research by the ABPI into patients and public engagement
- Foster improved patient and public engagement while remaining wholly compliant with regulatory requirements
- Evaluate the potential role of ‘influencers’ in promoting pharmaceutical products
- Is social media the key? In a world where misinformation is rife and people rely on AI for medical advice, should the rules be changed to pharmaceutical companies be able to directly communicate accurate information to the public?
- Do the current laws on patient engagement reflect the current needs and nature of society?
Andy Collier, Senior Policy Manager – Reputation, Association of British Pharmaceutical Industries
10.20 Bonus Session; Reserved For Acteon
10.35 Morning Refreshment Break With Informal Networking
11.05 Bonus Session; Reserved For Exclusive Conference Partner
Regulatory Updates & Trends
panel q&a
11.20 Stay Ahead Of The Curve & Unpack The Latest Regulatory Updates & Adopt A Dynamic Perspective To Consider What The Current Trends Mean For The Future Of Risk & Compliance
- Following regulatory updates, adopt a broader perspective on the changes occurring within the risk and compliance landscape: unpack the latest legislation coming into force in this industry and develop the most effective strategies for navigating any implications or consequences for your functions
- Discuss and debate the most pertinent legislation affecting this field and navigate the consequences and impact for your operations
- What’s next? Evaluate the current regulatory trends and discuss the future of the risk and compliance landscape to keep pace and evaluate the future of these functions in the face of global compliance challenges
Meredith Kennedy, Head of Compliance Eu Nth/Sth & Vice Chair of the EFPIA Ethics & Compliance Committee, Roche Pharma
Alicia White, Director, PMCPA
Corlia Van Der Walt, Director: R&D Partnerships & Legal Compliance, AstraZeneca
Third Party-Risk Management
Double Perspective
11.50 Facilitate Rigorous Monitoring & Robust Relationships With Third-Parties To Optimise Compliance Strategies Across A Global Supply Chain
- Apply proactive risk assessments and rigorous monitoring to ensure thorough due diligence and high standards for third parties
- Combine effective monitoring and due diligence with new strategies to dynamically foster constructive and compliant third-party relationships
- Expand your vision of third-party risk management to encompass a global perspective and develop a holistic approach that ensures high ethical, safety and compliance standards across an international scale
- What is the next evolution in third-party risk management? From intermediaries to sub-contractors and beyond… develop forward-thinking perspectives on the expansion and advancements in third-party risk management to assess the future of compliant relationships with partners
11.50 Perspective 1
Natalia Cojucaru, Senior Director, Ethics & Compliance, Novo Nordisk
12.10 Perspective 2
Lizanne Pistorius, Head of Patient Safety & Pharmacovigilance, Boehringer Ingelheim
Data Integrity, Analysis & Ethics
12.30 Proactive Data Integrity Approaches To Ensure Watertight Compliance Standards & Increased Patient Trust In An Increasingly Complex, International & Tech-Driven Data Landscape
- In light of the new European Health Data Space, how will approaches to data privacy be impacted? How will data integrity and privacy functions operate within this new context?
- Data Privacy Compliance through a global lens: adopt a dynamic approach and discover innovative strategies to navigate different data privacy laws in matters from clinical trials to marketing materials in the international data protection landscape
- As AI continues to evolve, proactively adapt compliance strategies to mitigate potential data privacy risks with AI usage
- As new and emerging technologies become increasingly visible and prominent in the data integrity landscape, delve into the best approaches to bolster patient trust in data privacy and integrity in this changing context
Ilvija Gruba, Regional Compliance Assurance Director for Middle East and Africa Privacy and Sanctions, Astra Zeneca
12.50 Lunch & Informal Networking For Speakers, Delegates & Partners
13.20 Interactive Hot Topic Peer-To-Peer Discussions
a) Patient-Centric Compliance
b) Cyber Security
c) Supply Chain & Vendor Risk Management
d) Monitoring
e) Auditing Inspections
f) Global Compliance Challenges
13.50 Afternoon Chair’s Opening Remarks
Kyriaki (Kiki) Merakli, Chief Compliance Officer, Sobi
ESG & Sustainability Compliance
PANEL Q&A
14.00 Ensure ESG Compliance In A Changing Sustainability Landscape & Foster A Proactive Approach To Maintaining Effective Monitoring & Initiatives
- How can you foster sustainability compliance on a global scale when the EU are issuing new legislation, but the US are withdrawing theirs? Navigate an often contradictory and inconsistent ESG landscape and adopt a proactive approach to tackling these challenges
- Delve into the new EU DR legislation to establish how to efficiently respond to these changing regulations and understand changing expectations for your organisation
- Address sustainability challenges in pharmaceutical manufacturing to develop optimal strategies to integrate ESG compliance throughout all company functions
- What does the future of ESG compliance hold? How to prepare for new developments and trends and encourage a forward-thinking approach to ESG
Dr. Qintao Liu FRSC PhD MBA BSc, Director, Compliance Human Biological Samples, AstraZeneca
Regulatory Frameworks
14.30 Adaptability, Proactivity, Efficiency: Drive The Shift Towards Risk-Based Regulatory Frameworks To Minimise Risk & Maximise Efficacy In Your Compliance Strategies
- Adaptability: develop vital strategies to ensure that your regulatory frameworks are robust and agile to adapt to necessary updates in the face of constantly changing legislation
- Proactivity: drive the way to risk-based regulatory frameworks that proactively address compliance challenges and promote continuous improvement in compliance strategies
- Efficiency: maximise the use of regulatory models that streamline processes, and develop clear metrics to assess their efficacy and effective implementation across the wider organisation
HCP Interaction & Engagement
Double Perspective
14.50 Ethics, Integrity & Transparency: Facilitate Ethical Interactions & Constructive & Compliant Relationships With HCPs
- Mitigate risks in interactions with HCPs and develop effective methods to ensure and enhance rigorous compliance in every aspect of HCP interaction and engagement
- Delve into the best practices in HCP engagement to cultivate holistic compliance strategies and prioritise ethics-driven decision making
- Navigate the changing media landscape as the media take an increasing interest in the relationship between pharma companies and payments to HCPs. How has this impacted the interactions with HCPs?
14.50 Perspective 1
Jacob Jose Palathingal, Director – Risk Insights & Reporting, Novartis International
15.10 Perspective 2
Charles-Edouard Castaigne, Head of Internal Audit Global Business Units, Sanofi
15.30 Bonus Session; Reserved For Exclusive Conference Partner
16.00 Afternoon Refreshment Break With Informal Networking
Compliance Cultures
16.30 Promote Positivity & Effective Training Techniques To Foster A Healthy Risk & Compliance Culture
- What are the tangible indicators for a positive risk and compliance culture and how can this be continuously monitored?
- What can people in leadership positions do to champion a positive culture and build healthy habits across the organisation?
- Develop effective training techniques and verify their impact to enhance understanding and seamlessly integrate a strong, positive compliance culture into daily operations
- Navigate how to foster a constructive approach to whistleblowing platforms and measures and determine the matters that should be routinely investigated
Enrique Grande, Head of Ethics & Compliance Iberia, Takeda
Anti-Corruption & Anti-Bribery
PANEL Q&A
16.50 Ensure Stringent Standards On Anti-Corruption & Anti-Bribery & Effectively Monitor Upcoming Regulatory Developments To Foster Adaptive Decision-Making Strategies
- Navigate the changes in the anti-corruption legislation and prepare for relevant developments in the geopolitical landscape to foster proactive and adaptive decision-making strategies across all functions
- How have things changed in light of the suspension and limitation of the Foreign Corrupt Practices Act in the US? What are the implications for European approaches to anti-corruption and anti-bribery?
- Ensure rigorous compliance with anti-corruption laws and develop robust tactics to monitor risks and maintain stringent standards across the organisation
Enrique Grande, Head of Ethics & Compliance Iberia, Takeda
Antoinette Keane, Executive Director, Head of Ethics & Compliance EUR/INT, Jazz Pharmaceuticals
Chris Muehl. Senior Director Compliance, GSK
Tamara Chisholm, Senior Legal Director, Global Compliance, Gilead Sciences
17.20 Afternoon Chair’s Closing Remarks & Official Close Of Conference
Kyriaki (Kiki) Merakli, Chief Compliance Officer, Sobi
