The Patient Centricity & Engagement Conference

23 NOVEMBER 2023 | AMSTERDAM

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Protect Your Organisation, HCPs, Patients & Stakeholders, Proactively Identify New Threats & Dangers With Potential To Disrupt & Effectively Navigate Constantly Changing Legislation For

Robust & Resilient Risk & Compliance Strategies
Across Pharma & Life Sciences

08.30 Registration, Informal Networking & GIC Opening Remarks

09.10 Morning Chair’s Opening Remarks

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Ben Kaye-Smith, Head Ethics Risk & Compliance Europe, Novartis Innovative Medicines

DATA PRIVACY

09.20 Defend Your Data & Your Business To Avoid Leaks & Breaches & Maintain High Levels Of Trust For Both Staff, Patients & HCPs

  • Identify the significance and sensitivity of personal health data, for patients as well as staff, and the potential as high-risk security targets
  • From IT departments to patient interaction, enhance connection, collaboration and communication to protect data in every aspect of the business
  • Examine the full data spectrum, from transparency reporting to GDPR regulations and omnichannel data… how will data privacy continue to evolve in 2023 and beyond?
  • Discover versatile systems to suit different budgets, needs and business sizes, from large pharma organisations to small healthcare or health tech start-ups

Antonios Roussos, Head of Global E&C Data Privacy & Group DPO, Astellas Pharma Inc

AI & AUTOMATION

PANEL 

Q&A 

09.40 Incorporate The Latest AI, Automation & Technological Advances To Streamline Business & Healthcare Practices Whilst Determining & Mitigating Potential Risks

  • What is the future of AI in pharma and life sciences? Examine the pros and cons and appraise the potential advantages, including the impact on regulatory practices
  • Analyse the systems and metrics which validate AI and automation systems, can they be improved, or better implemented internally?
  • Discuss and debate the ethics of AI, how can you ensure that AI is not unduly influencing patients and HCPs, or being influenced itself?
  • Putting patients first, always! Can AI pick up on certain trends that might impact patient safety?
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Vyomesh Patel, Area OEC Director (Aesthetics)-Western Europe and Canada, AbbVie

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Lizanne Pistorius, Senior Manager Global Patient Safety Operations, QMS & Risk Management, Nestlé Health Science/Aimmune Therapeutics

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Béatrice Nihoul, Senior Director, Global Compliance & Ethics, Galapagos GmbH

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Charles-Edouard Castaigne, Head of Internal Audit for Global Business Units, Sanofi

10.10 Bonus Session; Reserved For Exclusive Conference Partner

10.40 Morning Refreshment Break With Informal Networking

RISK ASSESSMENT

11.10 Boost Resilience, Flexibility & Agility In Your Pharma & Life Sciences Organisational Practices By Exploring Cutting-Edge Approaches To Gauging New Risks

  • How can we deal with unavoidable risks? Evaluate acceptable levels of risk to keep your business adaptable and propulsive while still remaining compliant across all levels
  • Next steps – how are these assessments acted upon? Practice zero trust to reinforce the importance of risk assessments as a serious matter, not just box-ticking exercises
  • Design mitigating actions and find practical and applicable solutions to the problems highlighted by actioning thorough internal risk assessments
  • Be proactive! How can pharma and life sciences stay ahead of the curve and shape outcomes in advance, rather than reacting to existing situations?

Dr Emilio Rubio, Head ERC SIR, Sandoz 

SUPPLY CHAIN

11.30 Assess Modern Supply Chain Challenges & Complexities To Drive Transparency, Compliance & Ethics While Retaining Efficiencies & Productivity

  • Every link matters! How well do you know each part of the pharma chain and the risks at every level? How can you guarantee compliance tier by tier?
  • Ensure you are keeping up-to-date on modern slavery, child labour and other critical human rights issues which can present an immediate threat to people, and a broader risk to the pharmaceutical and life sciences sectors
  • Gaps, delays, unavailability of resources – investigate actionable solutions to mitigate problems without crossing into noncompliance
  • From raw materials to transportation, how can clarity of communication and co-operation keep the chain compliant?

ANTI-CORRUPTION & ANTI-BRIBERY

PANEL 

Q&A 

11.50 Maintain Integrity & Transparency At Every Level Of Business With Clear Codes Of Ethical Conduct That Put Honesty First

  • Critical questions answered: how can corruption occur? What forms can bribery take? Where and when are processes and transactions at their most vulnerable
  • Staying vigilant – not all forms of corruption are immediately apparent, so how can you best prepare for and determine the traps and pitfalls to watch out for
  • Examine practical pointers for avoiding undue influence, practising transparency, and verifying fair market values. These matters may not always be as clear as we would hope, so how can we mitigate this?
  • Delve into a range of potential bribery problems in order to understand how this issue can impact everything from sponsorship and remote processes to telemedicine and the digital market across pharma and life sciences today
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Enrique Grande, Head of Ethics & Compliance Iberia, Takeda

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Nicola Galtieri, Head of Ethics & Compliance – Human Pharma, Boehringer Ingelheim

Ben Kaye-Smith, Head Ethics Risk & Compliance Europe, Novartis Innovative Medicines

REGULATION FRAMEWORKS

12.20 Protect Your Pharma & Life Sciences Organisation From Financial & Reputational Harm, Ensure Patient Safety Is At The Forefront Of Your Practices & Best Prepare To Navigate Constantly Changing Legislation

  • Heighten your awareness and respond in a timely manner! In a world of constantly evolving regulations, how can you keep up and stay on top of the incoming implications to respond effectively?
  • Failing to comply is not an option and fines are not the only issue… in a world where reputational damage can be more harmful in the long run ensure your regulatory frameworks and models are robust and agile to adapt to necessary updates 
  • How are strong regulatory frameworks built and embedded organisation-wide? Investigate the policies and content, from a local to global level in order to decipher which areas are not covered, and how can you best proceed where these frameworks aren’t in place?
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Lizanne Pistorius, Senior Manager Global Patient Safety Operations, QMS & Risk Management, Nestlé Health Science/Aimmune Therapeutics

12.40 Lunch & Informal Networking For Speakers, Delegates & Partners

13.10 Informal Breakout Discussions

A) HCP Engagement & Interaction

B) Anti-Bribery & Anti-Corruption

C) Patient Safety & Collaboration

13.40 Afternoon Chair’s Opening Remarks

Bennett Lau, Compliance Officer Policy & Procedures EUROPE, Daiichi Sankyo GmbH

3RD PARTY RISK MANAGEMENT

13.50 Session 1: Deep Dive & Evaluate Your Third-Party Relationships To Ensure Clear, Credible & Compliant Communication From Inside & Outside Your Business & Stay Protected On All Sides

  • Explore the hidden dangers in 3rd Party relationships – is everyone playing by the rules? How do the challenges and expectations differ from big pharma to smaller companies?
  • Verify 3rd Party information to ensure best business practices are being followed, and avoid the risks (both obvious and hidden) that come from box-ticking and cutting corners
  • Risk remediation – sometimes budget, specialism or availability might mean that a risky option is the only option… in these cases, how can you evaluate whether the risk is reasonable? 

Christian Mühl, Head Ethics & Compliance, Member Global Leadership Team, Partner & Emerging Markets, Alnylam Inc

14.10 Session 2: Deep Dive & Evaluate Your Third-Party Relationships To Ensure Clear, Credible & Compliant Communication From Inside & Outside Your Business & Stay Protected On All Sides

  • Explore the hidden dangers in 3rd Party relationships – is everyone playing by the rules? How do the challenges and expectations differ from big pharma to smaller companies?
  • Verify 3rd Party information to ensure best business practices are being followed, and avoid the risks (both obvious and hidden) that come from box-ticking and cutting corners
  • Risk remediation – sometimes budget, specialism or availability might mean that a risky option is the only option… in these cases, how can you evaluate whether the risk is reasonable? 

Teodora Alexandrova, Associate Director ECP (Ethics, Compliance, Privacy) EMENA – Controls and Processes, Accord Healthcare

Chris Key, Senior Director – Compliance, Ethics and Privacy Europe and MENA, Accord Healthcare

CYBER SECURITY

14.30 Stay Safe & Secure In The Fast-Paced, Ever-Evolving World Of Cyber Attacks By Identifying & Preparing For Potential Dangers, Implementing The Latest Security Strategies & Always Keeping Two Steps Ahead

  • Lay effective groundwork for large-scale digital transformation and ensure consistent performance during modernisation programmes
  • Is RPA always the way to go? Understand the digital transformation programmes that can add the greatest value to the business without breaking the bank
  • How can stakeholders be actively engaged in digital transformation, and inspire the behavioural change needed to unlock the power of transformational programmes?
  • When the economic situation is uncertain, how can we ensure top-down buy in for digital transformation and drive long-term cost savings?

Olawale Alimi, Director, Data Policy (R&D Data Risk and Compliance), AstraZeneca

14.50 Bonus Session; Reserved For Exclusive Conference Partner 

15:20 Afternoon Refreshment Break With Informal Networking

SANCTIONS & INTERNATIONAL RISK

15.50 Determine The Threats & Dangers From The Current Geopolitical Situations, Track The Global Market & Anticipate The Next Developments Set To Disrupt Risk & Compliance In Pharma & Life Sciences

  • From Russia and Ukraine to China and Taiwan, increase your awareness of the volatile geopolitical climate and evaluate threats to the sector by understanding the ongoing and developing situations
  • Ensure international compliance and steer clear of future complications by knowing the current sanctions and anticipating how they might develop over time
  • What new sanctions might need to be introduced, and how will they be enforced? Look ahead to reduce the potential for future shocks?
  • Avoid instability and mitigate uncertainty – how are manufacturing and distribution processes being affected? What are the alternatives?

ESG

16.10 Enhance Sustainability Practices, Meet Critical Expectations & Maximise Practical Applications To Seamlessly Embed Into Existing Strategies For Maximum Impact

  • Exceed expectations of staff, HCPs, patients and shareholders by utilising and maximising existing practices to boost ESG compliance across the board
  • Keep it simple: how can ESG regulatory practices be seamlessly embedded into existing programmes and frameworks so that everything works together smoothly?
  • Explore practical solutions and identify which programme elements are most relevant to ESG, and how adjusting KPIs and reporting can help meet and exceed ESG expectations

Stephanie Wingrove, VP & Global Head of Ethics and Compliance, Galapagos

EMERGING RISKS

PANEL 

Q&A 

16.30 Identify The Latest Threats To The Sector, Assess Possible Business Impact & Forecast Future Developments To Protect Your Business From Risk & Compliance Risks

  • Get ahead of the curve – rather than running behind reality, and take proactive steps towards problem prevention for proven and effective results
  • Maximise awareness of the road ahead, as biotech, new products and new processes can all bring new challenges as well as solutions, how are the regulations likely to change moving forward?
  • Gauge the impact of contemporary geopolitics on the pharmaceutical and life sciences industry, and anticipate how these situations might evolve over time in order to influence future strategies and frameworks
  • Learn more about how digital developments, like cyber security and data privacy, interact with other forms of risk to examine what paths these may follow in the future?

Sharmeen Ali Khan, Head of Global Investigations, Monitoring & Trade Compliance, Amgen

Tamara Chisholm, Senior Legal Director, Global Compliance, Gilead Sciences

17.00 Afternoon Chair’s Closing Remarks & Official Close Of Conference

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Please check the Patient Centricity & Engagement Conference website regularly for programme updates and confirmed speakers. For more information or to get involved, please call 44 (0)20 3479 2299 or email info@patientengagementconference.com

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