Seize AI & Tech Opportunities, Monitor New Risks & Regulations, Embed Controls & Safeguard The Business During Times Of Change
Revolutionise Risk & Compliance Strategies Across Pharma & Life Sciences
2nd Annual, One-Day Sector-Targeted Conference & Networking Exhibition, Central London, 2nd October 2024
08.30 Registration, Informal Networking & GIC Welcome
09.00 Morning Chair’s Opening Remarks
Christina Dimanova, Regional Compliance & Integrity Officer, Europe region MIDI, Boehringer Ingelheim
Geopolitics & International Risk
09.10 From Elections To Conflict To Sanctions: Increase Your Agility To Adapt & Navigate Through Turbulent Times By Preparing For Changing Risks, Ethical Challenges & The Regulatory Impact Of Operating A Global Pharmaceutical Business In A Divided World
- Planning for operational continuity and ongoing compliance in the face of emerging risks and new regulations in a fast-moving world – how can you craft agile frameworks which allow you to anticipate, react and respond?
- Collaborate with operations to ensure they are aligned with evolving regulations and the international conduct – all while steadfastly upholding ethical standards and prioritising patient needs
- From elections to conflict to sanctions, keep an eye on the geopolitical landscape and understanding exactly what different outcomes could mean for your function
- Remain vigilant in staying updated on regulatory frameworks and ethical conduct throughout the supply chain concerning human rights, corruption, fraud, potential sanctions breaches and anti-terrorism
Ilvija Gruba, Regional Compliance Assurance Director for Middle East & Africa, Privacy & Sanctions, AstraZeneca
AI & Automation- Panel & Q&A
09.30 Design Proactive Regulatory Frameworks, Policies & Codes Of Conduct Around AI To Enable Effective AI Adoption Across All Functions & Protect The Business From Risks
- The challenge we face: creating and enforcing coherent, ethical and compliant internal AI policies for different applications throughout the business while managing different risk appetites
- Harness AI’s potential to streamline operations, automate tasks and optimise internal audits to enhance compliance functions’ efficiency
- We all know the risks of AI – what is the level of resourcing required to minimise threats, secure vulnerabilities and ensure watertight compliance?
- Combat the ambiguity and uncertainty of AI’s evolution over time with consistent checks and validation to maintain control and ensure it remains fit for intended use
- Influence internal players to create responsible AI behaviours: governance processes, training and education to ensure awareness of blind spots, bias, security and patient safety
- As digital and AI explode across the business world, the GRC responsibility and complexity increases, how is the EU AI Act playing out in day-to-day several months down the line and what do we anticipate the next regulatory updates will focus on?
Jonathan Vogelsang, Ethics, Risk & Compliance Director International, Novartis Pharma AG
Moez Youssef, Ethics Risk & Compliance Global Director, Oncology, Novartis
Evgeny Tilezhinsky, Legal & Compliance Director, Kyowa Kirin International
Tetiana Isaieva, Head of Compliance EEMEAIS, Central and Eastern Europe, Middle East, Africa, Indian Subcontinent, Roche
Regulatory Frameworks- DOUBLE PERSPECTIVE
10.00 Navigate Constantly Changing Legislation To Protect Your Pharma Organisation, Ensure Patient Safety, Respond To & Minimise Risks & Best Enable Business Continuity
- Drive the shift towards risk-based regulatory frameworks to proactively address compliance challenges
- 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
- Training, training, training: ongoing rigorous compliance training which keeps everyone up to date with new laws and reinforces what they can/cannot do
- Implement agile validation methodologies to streamline processes and foster positive relationships with the wider organisation
- Develop clear metrics to assess the efficacy and seamless integration of regulatory frameworks to promote transparency, adaptability, and continuous improvement in compliance strategies
10.00 Perspective 1
Margarida Brita da Cruz, Legal & Compliance Manager, Fresenius Kabi
10.20 Perspective 2
Maria-Giovanna Gualazzi, Data Transparency & Regulatory Disclosure/EU CTR Lead, Ipsen
10.40 Bonus Session; Reserved For Exclusive Conference Partner
11.10 Morning Refreshment Break With Informal Networking
Third-Party Risk Management- DOUBLE PERSPECTIVE
11.40 Foster Rigorous, Robust Relationships With Third Parties Governed By Clear Protocols & Assessments To Ensure Uncompromising Regulatory Compliance Throughout The Entire Supply Chain
- From compliance monitoring to internal audits how can you create meaningful third-party checks which leverage assessment data to drive improvements and fine-tune the partnership?
- Conduct proactive risk assessments and minimise threats with the right TPRM tools and methodologies
- Competing demands: where third parties have multiple client relationships to maintain, how can we collaborate with suppliers to ensure the highest standards are consistently met?
- In the light of the EU’s CSDDD, is third party enough? How can you ensure due diligence is done on fourth and fifth parties and remain compliant all the way through the downstream supply chain?
- From digital agencies to distributors and raw materials suppliers… exploring the differing risks and vulnerabilities per third party category – what represents the greatest challenge?
11.40 Perspective 1
Anastasia Troyan, Senior Director Global Compliance & Ethics, Teva Pharmaceuticals
12.00 Perspective 2
Antoinette Keane, Executive Director, Head of Ethics & Compliance EUR/INT, Jazz Pharmaceuticals
The Strategic Role of Compliance- PANEL & Q&A
12.20 Getting A Seat At The Table: Advocate For The Value Of The Ethics, Risk & Compliance Function As A Strategic Partner To Business Goals To Encourage Widespread Support & Ethics-Driven Decision Making
- Champion ethics-centred decision-making in organisational compliance, emphasising the paramount importance of ethical choices in broader business contexts
- Elevate compliance as a strategic ally to business decisions, through highlighting its pivotal role in fortifying reputation and cultivating positive stakeholder relationships
- Employ persuasive tactics to rally wider business support for compliance practices, through comprehensive training programmes to enhance understanding and seamlessly integrate compliance into daily operations
- Establish mechanisms to enforce accountability across departments, fostering continuous improvement and minimising friction in compliance processes
- Communication is key! Clearly articulate framework updates to strategically implement new compliance and monitoring programs to ensure widespread adoption throughout the organisation
Dr Rafał Rybicki, Global Business Services Head of Legal & Compliance Services, Boehringer Ingelheim Poland sp. z o. o.
Rashanda Hathaway, Vice President, Compliance & Ethics, European Markets & Japan, Bristol Myers Squibb
Nakhli Khoury, Compliance & Ethics Head Switzerland & Austria, Bristol Myers Squibb
Jo Steele, Associate Director Ethics & Compliance, UCB Pharma
Tetiana Isaieva, Head of Compliance EEMEAIS, Central and Eastern Europe, Middle East, Africa, Indian Subcontinent, Roche
Hannes Oswald-Bruegel, Global Head Pharma Compliance Office, F. Hoffmann-La Roche AG
13.20 Lunch & Informal Networking For Speakers, Delegates & Partners
13.50 Peer-To-Peer Discussions
a) HCP Interaction & Engagement
Anne Fray, Associate Director – Ethics & Compliance UK, Eli Lilly and Company Limited
b) Cyber Threats
c) EU Updates
d) Emerging Risks
14.10 Afternoon Chair’s Opening Remarks
Maria-Giovanna Gualazzi, Data Transparency & Regulatory Disclosure/EU CTR Lead, Ipsen
Data Privacy
14.30 Proactively Ensure Compliance With Evolving Technologies, Safeguarding Patient Data Privacy, Mitigating Risks, & Fostering Trust Across Diverse International Data Protection Landscapes
- Proactively adapt compliance rules to evolving technologies like AI, safeguarding patient data privacy and averting infringements
- Mitigate internal and external data risks and conduct rigorous audit trials to validate data integrity, ensuring adherence to GXPs and combat cyber threats
- Advocate for data privacy initiatives that bolster patient trust across the wider business ecosystem
- Strategically navigate diverse international data protection landscapes by staying informed and implementing tailored compliance strategies
14:30 Perspective 1:
Antonios Roussos, Head of Global E&C Data Privacy & Group DPO, Astellas Pharma Inc.
14:50 Perspective 2:
Laura von Hertzen, Global Privacy Lead & Head of Compliance for International, ViiV Healthcare
Afternoon Discussion Zones
15.10 Networking & Discussion Opportunity
a) Whistleblowing
b) Clinical Trials
c) Cyber Attacks
d) Operational Resilience In Pharma
e) Fraud Detection
f) Sales Force
g) Climate Risks
Risk Assessment
15.30 New Strategic Monitoring Tools, Risk Assessment Approaches & Innovative Risk Controls To Comprehensively Assess & Address Emerging Risks To Deploy Agile Compliance Responses
- Monitoring as a predictive and strategic ally in business compliance, ensuring its meaningful integration and effective day-to-day use
- Define precise controls and assess risks comprehensively, to stay vigilant to emerging risks and maintain a balanced approach to internal controls
- Re-evaluate future risk controls to enhance accuracy and sophistication, enabling proactive risk management
- Cultivate efficient relationships with legal teams to develop anticipatory and agile risk response mechanisms, bolstering compliance readiness and adaptability
Daria Zygmunt- Grochal, Head of Legal and Compliance, Roche Poland
15.50 Bonus Session; Reserved For Exclusive Conference Partner
16.20 Afternoon Refreshment Break With Informal Networking
HCP Interaction & Engagement
16.50 Balance Commercial With Clinical Considerations While Remaining Compliant On Every Channel For Transparent Relationships With HCPs
- Ensure the changing pharma-HCP relationship does not mean the blurring of promotional vs non-promotional lines: from scientific to sales reinforce strict separation of messaging
- Cultivate compliant relationships with HCPs built on transparency in the face of ever more time pressure for medical and commercial to meet their goals
- Uphold compliance standards across diverse interaction platforms, leveraging digitalisation, AI, and omnichannel approaches to empower HCPs at the local level while adhering rigorously to regulatory requirements
Zohra Larbi, Global Compliance Manager, Guerbet
Anti-Corruption, Anti-Bribery, Whistleblowing
17.10 Harness Cutting-Edge Technology, Monitoring Tactics & Whistleblowing To Combat Corruption, Safeguard Reputation & Tackle Anti-Trust Challenges
- Deploy stringent tactics to monitor and thwart corruption, particularly at borders and throughout the pharmaceutical supply chain, amidst geopolitical turmoil
- Swiftly grasp and adapt to evolving regulatory frameworks to ensure seamless compliance, effectively mitigate corruption-related risks, safeguard reputation and foster unwavering trust with stakeholders
- How have things changed in light of the EU Whistleblower Directive? How can compliance professionals handle whistleblowing channels and determine what should be routinely investigated?
- Navigate complex conflicts of interest among patients, healthcare providers, and third-party entities by implementing fair and transparent practices
- Employ accelerating AI and automation to enhance detection of bribery red flags and bolster proactive risk mitigation within pharmaceutical operations
Gabor Sulyok, Head of Ethics Risk Compliance, Sandoz UK
Benedetta Cicconi, Senior Lawyer & Compliance Manager Italy, Merck Serono SpA
Chris Key, Senior Director – Compliance, Ethics & Privacy Europe & MENA, Accord Healthcare
Karen Allman, VP, Global Head of Compliance, ViiV Healthcare
17.40 Afternoon Chair’s Closing Remarks & Official Close of Conference
