Programmes

Online Trainings

International Risk Management in Life Sciences

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dates

31 May - 25 Jun 2021

Duration

4 WEEKS

Fee

EUR 650

Language

English

Description

This four week online course aims to provide an initial analysis of the Duties of the Board, Management Team and Legal / Compliance personnel when it comes to managing key complex risk areas in today’s dynamic Life Science sector. It also explores the key risk matters which are typically identified through Compliance gap analyses, structured audits as well as internal investigations. The course also covers “high value” risk areas, which occupy considerable time, money and strategic management planning (as well as external scrutiny). There will be opportunities to assess and discuss the types of violations which have attracted cross jurisdictional enforcement scrutiny and significant fines, as well as the types of conditions which are often imposed in a corporate criminal settlement agreement. An important focus will be on the recent DOJ guidance on structuring a robust Corporate Compliance program.

Lastly, there will be an exploration into the role (and increasing importance) of the Corporate Monitor, and how this settlement tool is deployed by Government Agencies to incentivise timely rehabilitation of past misconduct and improve culture.

The IACA International Risk Management in Life Science course will address several “high value” industry risk areas, which have been the focus of past enforcement actions, and which will be the basis of some focused case study analysis. The aim is to gain key insights into the optimum deployment of Legal / Compliance resources in an organisation, so as to consistently meet expected legal standards and be able to readily advise Senior Management / the Board of material issues that should be prioritised and expeditiously addressed. It also offers practical solutions which can be adopted by Legal / Compliance / Risk Professionals when detecting, managing and monitoring material risks in the international markets. 

The topics are tailored for seasoned professionals, with the aim to provide pragmatic “problem solving” approaches and to enhance the risk management “tool box” of corporate risk professionals in an increasingly fast evolving legal / regulatory environment.

Learning objectives

By the end of this course, participants should be able to:

  • Appreciate the critical governance role of the Board and Management Team, and how Legal / Compliance can add real value in strategic risk management
  • Understand the “tools” typically deployed to detect high value risk areas and deploy meaningful / defensible tactics to address “internal control weaknesses.
  • Analyze key “learnings” from recent enforcement actions and consider material (or high value) risk areas which present themselves in the international markets
  • Consider some resonating DOJ / SEC case studies from both a Pharma and Medical Devices perspective
  • Get an appreciation of the US DOJ Principles of Federal Prosecution of Business Organizations
  • Gain insights into the DOJ’s recent guidance on Corporate Compliance programs and how this can be incorporated into a robust and savvy program
  • Appreciate what is involving when a Corporate Monitor is appointed and how best to work effectively and efficiently in addressing the monitorship mandate
  • Will be provided with essential “risk management” tools to approach their roles, and to be seen as a Centre of Excellence by the Board and Management Team/s.

Structure and Workload

The course is delivered online, and includes pre-recorded lectures, synchronous live lectures, self-assessments, individual assignment and online discussions.  

Week 1:

Duties of the Board & Role of Legal / Compliance

Internal Risk Assessment – Detection

Week 2:

Case Studies: Pharma & Medical Devices

Recent Department of Justice Guidance on Corporate Compliance Programs

Week 3:

Emerging Risks and Enforcement Activity in Life Sciences

Week 4:

The Corporate Monitor – New Corporate Tza

This course is for

Legal, Compliance, Risk Managers, Finance / Audit, Management and Human Resources professionals interested in knowing more about internal investigations’ best practices.

Certificate

A Certificate of Complettion will be issued to all participants who successfully complete the course.

Lecturer

Maija Burtmanis

Maija is an Australian qualified senior Legal / Compliance Life Sciences Professional, whose career has primarily been based in the international markets. She has worked as a senior lawyer and compliance professional for companies such as Pfizer, Novartis and Shire BioPharma and has covered jurisdictions which include Russia, Japan, China, India and the breadth of Asia Pacific. 

During her career, Maija has worked on many aspects of legal / compliance “risk management” which lie at the heart of “business integrity” success for leading multinational companies: these include, guidance on the ethical conduct of foreign clinical trial programs; assistance with sensitive interactions involving patients, patient organisations, healthcare providers and government representatives; education, training and advice on FCPA, Anti-Bribery, Code of Conduct and CIA requirements; legal assistance with both internal and external investigations; corporate law strategic (M&A) projects.

She is a Co-Founder of the APAC Healthcare Legal / Compliance industry group (estbalised in 2008) and often liaises with other industry groups and partners to advance key issues which impact this highly regulated industry.

Payment options

card payment

FEE - EUR 650.00

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20% discount - EUR 520.00

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15% discount - EUR 552.50

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10% discount - EUR 585.00

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