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17-08-2020 (Live Online)

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Live Online: Pharmaceutical Ethics & Compliance

17 – 20 August 2020 | 4-Day Live Online | 1:30 pm – 5:00 pm (SGT)

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Register 2 Delegates & the 3rd attends FREE!

overview

About The Course

To help you stay on the pulse of enforcement trends, this masterclass brings together latest updates on global regulations and best practices around the world for pharmaceutical ethics compliance and risk management.

Throughout 4 modules, attendees will examine various compliance requirements underpinning clinical operations, medical affairs, drug pricing, data transparency, patient interaction and product communications. Case studies will include ethics and compliance best practices globally, non-conformance handling, legal breaches as well as how leading players are digitising their compliance monitoring process.

 

Key Learning Outcomes & Case Studies Include

  • International Trends, Regulations and Best
  • Practices Around the World for Global Compliance
  • Corporate Integrity Agreements and settlement trends
  • Patient interaction compliance – clinical to commercial
  • Clinical trials and touch points for managing compliance risk
  • Tracking and Auditing Investigations
  • Medical Affairs compliance and managing
  • HCP engagement
  • Third-party due diligence and compliance management
  • Driving compliance across business units and divisions
  • New risk profiles and how compliance needs to respond
  • Modernising compliance & ethics monitoring

pricing

Packages Price
Live Online LearningSGD $2876Early Bird

Register 2 Delegates & the 3rd attends FREE!
Group rate is based on normal rate of 2-day main conference package only.
For Group Registrations, email register@informa.com or call +65 6508 2401

 

  • Special Group Discount pricing is applicable to groups of 2 or more delegates from the same organization registering for the same event, at the same time.
  • Fee stated is the discounted price PER DELEGATE. Only one discount applies – either the early bird rate OR the Special Group Discount.
  • A 7% Goods & Services Tax (GST) is applicable to all Singapore based companies for Singapore venue.
  • View payment terms and bank transfer details, click here »

Trainer

Kristy Otterbein
Pharmaceutical Compliance Professional | Independent Consultant

Kristy has over 25 years’ experience in pharmaceutical industry with certification in US and European Pharma Compliance. She has a wealth of handson knowledge of regulatory requirements including FDA, OIG Regulatory Guidance, PhRMA, IFPMA, EFPIA Code requirements and other global national codes of ethics. She worked across numerous positions including Global Compliance Training & Communications Programme Manager (Takeda) and GxP Training specialist (TAP Pharmaceuticals – a JV between Abbott Laboratories and Takeda Pharmaceutical).

Some of her projects include:

  • Developed & implemented company-wide strategies and annual training programme on Code of Conduct and Compliance Policies for Interactions with Healthcare Professionals
  • Managed the development and deployment of a Compliance Awareness Assessment programme
  • Maintained QA departmental PPG (Policies, Procedures, Guidelines, and Work Instructions)

Kristy has spoken in various international conferences including HCCA Research Compliance Conference, FCPA & Anti-Corruption for the Life Sciences Industry.

Live Online Learning

Stay Home. Skill Up!

The current Covid-19 pandemic has put strains on various areas of business, especially when it comes to deriving commercial value from new initiatives. During this phase of self-isolation and working from home, we can help you meet your professional development needs and you can still take your professional development plans to the next level.

To support your learning goals we have converted our face-to-face trainings to LIVE Online Sessions. This way you can continue to attend live and interactive training sessions within the virtual classroom space where you can see and speak, with your Subject Matter Expert and other participants.

Benefits of Live Online Learning

Aimed at offering you immediate, high-quality practical information whilst minimising time and expenditure associated with travelling, our digital training platform enables you to interact in real time with course directors and remotely network with your fellow participants.

  • Classroom Experience: Progress with fellow participants as you would in an on-site class
  • Guaranteed cost-effectiveness: Travel budget saving, plus 20% price advantage for online participation
  • Controlled environment with speakers managing the Q&A and discussions and tools for enhanced interactions
  • Module-based approach to effectively manage your time and revisions
  • Earn your Digital Certification and broadcast your achievements to your peers
  • Onboarding: Available for all attendees
  • Proven and secure training platform

 

Click here to know more >

Digital Badge

Upon completion of this training course, participants will earn a digital badge.

Eligibility:
Attend and participate in the 2 full days of training course duration, led by the designated training expert

Available to:
Seminar attendees

Digital Badge FAQ >

Agenda

MODULE 1

LATEST UPDATE ON GLOBAL CODES

  • Anti-bribery, Anti-corruption
    • Recent Enforcement Actions Against Companies/Individuals
  • Data collection, analytics & monitoring processes
  • HCP Marketing & Engagement
    • Impacted Functions/Activities
    • Review Country Standards (hospitality, FMV, etc.)
    • Country Transparency Data Reporting Requirements
    • Exercise: HCP Engagement Activities

 

COMPLIANCE MATTERS ARISING FROM COVID-19

  • Fraud, bribery & corruption – what have we learned from Covid-19 and previous outbreaks?
  • Engaging with healthcare professionals
  • Internal investigations in a post-pandemic world
  • Drug shortages, resource allocation & drug repurposing
  • Compliance risks from disrupted supply chains & third parties
  • Case Studies: Treatment & drug transparency
    • Transparency in payment & contracting processes

Discussion: Dealing with off-label usage, self-medication & drug stockpiling

 

COMPLIANCE IN SALES & MARKETING

  • Applicable compliance policies
  • Foreign Corrupt Practices Act impacts on HCP engagements
  • Product communications – Pre-approval to Post-approval
  • Permissible and impermissible activities
  • Exercise: Sales & Marketing compliance risk assessments
    • Clinical/Research Study and Educational Grants
    • Dissemination of Off-Label Information
    • Contractual Payments/Arrangements
    • Sampling and Free Goods
    • Product Trials
    • Medical Education Programmes
    • Professional Service Agreements with Physicians

 

MODULE 2

PATIENT AFFAIRS COMPLIANCE

  • Principles, rules
    • Patient interaction
    • Patient organisations
    • Patient assistance programmes
  • Criteria, prohibitions
  • Documentations

 

ETHICS & COMPLIANCE IN CLINICAL TRIALS MANAGEMENT

  • Key framework of clinical trial regulations – Globally
  • Overview of recent developments in clinical trial regulations
  • Ethics committee submissions & approvals
  • Contracting
  • Data protection
  • QA, GMP & GxP training initiatives

 

THIRD-PARTY DUE DILIGENCE & RISK ASSESSMENT

  • Thirrd party risk management (TPRM) assessment
  • Due diligence and criteria
    • Antibribery & corruption
    • Confidentiality
    • Data privacy
    • Employment practices
    • Governance
    • Product security
    • R&D ethics
    • HSE compliance
    • Conflict of interest
    • 3rd party training
  • Technologies
  • Exercise: Exploring due diligence dilemmas

 

MODULE 3

KEY ELEMENTS OF AN EFFECTIVE COMPLIANCE PROGRAMMES AND STRATEGIES

  • Review Common Global Elements
  • Understand importance of Compliance Culture & Value
  • Compliance Organizational Structure
  • Roles and Responsibilities
  • Compliance Programs & Documentation
  • Program Effectiveness

 

COMPLIANCE MONITORING

  • Functional Process Monitoring
  • Business Activity Monitoring
  • Goals
  • Tools/Toolkit

 

RESPONSIBILITIES & OVERSIGHT

  • Investigating & addressing non-compliance
    • Investigation process overview
  • Roles & responsibility
  • Preventive actions
  • Corrective Actions Procedures

 

MODULE 4

DIGITISING & MODERNISING COMPLIANCE STRATEGIES

  • Pressure and challenges
  • Automating global interaction compliance review of HCP/HCO engagement requests
  • Compliance considerations in technology usage for HCP & patient engagements

 

COMPLIANCE MONITORING TECHNOLOGIES

  • Internal compliance training solutions
  • Expense reporting
  • Process automation, RCA, continuous controls
  • Compliance reviews of HCP engagement requests
  • Monitoring of third parties

LEGAL CASE STUDIES ON PHARMA ETHICS & COMPLIANCE

when & where

17 - 20 Aug 2020

4-Day Live Online
1:30 pm – 5:00 pm (SGT)

On-site & in-house training

Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?

Talk to us about an on-site/in-house & customised solution.

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