ERM and the Pharmaceutical Industry. Risk  An innate part of every aspect of life, and the business environment is of no exception  Severity, both in.

Slides:



Advertisements
Similar presentations
Lisanne Sison Director ERM Bickmore
Advertisements

Chapter 10 Accounting Information Systems and Internal Controls
Control and Accounting Information Systems
Introduction to Enterprise Risk Management (ERM)
ERM in the Rating Evaluation CAMAR Fall Meeting November 29, 2007 Thomas M. Mount, ACAS, MAAA Andrew Colannino, Vice President A.M.Best Company.
Tax Risk Management Keeping Up with the Ever-Changing World of Corporate Tax March 27, 2007 Tax Services Bryan Slone March 27, 2007.
2011 Governance, Risk, and Compliance Conference August 29 – 31, 2011 / Orlando, FL, USA The Top Four Essential Objectives to Auditing ERM Stephen E. McBride,
Eliot M. Stenzel, CPA,CIA IIA Instructor for many years Risk Based Auditing.
Office of the Secretary of Defense – Comptroller Financial Improvement and Audit Readiness Directorate Unclassified 17 September 2014 GAO Revised “Green.
Enterprise Risk Management Rick Gorvett, FCAS, MAAA, ARM, FRM, Ph.D. Actuarial Science Professor Departments of Mathematics and Finance University of Illinois.
Under the Microscope Business Officers Meeting March 7, 2006 Presented by Randy Van Dyke Internal Control.
Chapter 7 Control and AIS Copyright © 2012 Pearson Education, Inc. publishing as Prentice Hall 7-1.
UNIVERSITY OF PENNSYLVANIA 1 ASSESSING AND MITIGATING BUSINESS RISK USING INTEGRATED INTERNAL CONTROL FRAMEWORK.
IDENTIFYING RISKS AND CONTROLS IN BUSINESS PROCESS
Operational Auditing--Spring Operational Auditing Spring 2011 Professor Bill O’Brien.
Operational Auditing--Spring Operational Auditing Spring 2010 Professor Bill O’Brien.
Risk Assessment Frameworks
CORPORATE RISK MANAGEMENT & INSURANCE BY R P BLAH D.G.M. INCHARGE THE ORIENTAL INSURANCE COMPANY LIMITED REGIONAL OFFICE BHUBANESWAR.
Information Systems Controls for System Reliability -Information Security-
Career Opportunities in Statistics John Borkowski Montana State University Panel Discussion Pattaya Conference on Statistics Pattaya, Thailand.
Control environment and control activities. Day II Session III and IV.
Chapter 4 Internal Controls McGraw-Hill/Irwin
Good Clinical Practice GCP
Nicosia, May 15th, th International Conference Challenges facing aviation safety - An airlines’ perspective.
The role of internal audit in enterprise-wide risk management (ERM)
Transitioning to the COSO 2013 Update.  Released on May 14, 2013  Designed to build upon the foundation of the 1992 Framework  Will supersede the 1992.
2014 PAMIC Financial Management Seminar Enterprise Risk Management Presentation Jeff Pratt – Director FP&A September 30, 2014.
IT Risk Management, Planning and Mitigation TCOM 5253 / MSIS 4253
Travel Risk Management Today’s Challenges in a Risky Environment (C) iJET International, Inc. All rights reserved.
Chapter 3 Organizational Environments and Cultures Dr. Ellen A. Drost
Introduction to Internal Control Systems
Vijay V Vijayakumar.  SOX Act  Difference between IT Management and IT Governance  Internal Controls  Frameworks for Implementing SOX  COSO - Committee.
This Lecture Covers Review of Internal Control Definitions.
Chapter Three IT Risks and Controls.
Internal controls. Session objectives Define Internal Controls To understand components of Internal Controls, control environment and types of controls.
INTRODUCTION Why AIS threats are increasing
Copyright T. Rowe Price. All rights reserved 1 Ms. Deborah D. Seidel of T. Rowe Price Financial Services Vice President and Manager of Compliance.
1 Intellectual Property in the Innovative Pharmaceutical Industry *** June 12, 2006 Gregg C. Benson Assistant General Counsel – Intellectual Property 1.
IRS Enterprise Risk Management (ERM)
From the Lab to Market Unit 3.04 Understanding Biotechnology research & Development.
Bruce Branson Associate Director, NC State ERM Initiative September 27, 2012.
Committee of Sponsoring Organizations of The Treadway Commission Formed in 1985 to sponsor the National Commission on Fraudulent Financial Reporting “Internal.
The Institute and the Profession: 1 Personalize your title and presenter here. The Institute and the Profession The Institute and the Profession: 1.
Conducting Compliance Assessments and Building Internal Controls In Pharmaceutical R&D Third Annual Medical Research Summit – Session 2.01 Michael Swiatocha.
The Connection between Risk Management and Internal Control in Organizations Mag. Norbert Wagner Budapest,
Geneva Association/International Insurance Society Research Presentation, Chicago Enterprise Risk Management in the Insurance Industry Madhusudan.
1 Introducing Enterprise Risk Management (ERM) - The KOC Experience November 2012 Khaled Al-Awadhi Risk Management Team Kuwait Oil Company.
The FDA Regulatory and Compliance Symposium Preparing for the FDA’s Risk-Based Inspections Presented By: Martin Browning, EduQuest, Inc.
Where Do We Go From Here: Risk Management after the Financial Meltdown Kevin McCabe Wells Fargo Audit Services EVP & Chief Auditor FIRMA 24 th National.
Agenda for Session Compliance in Clinical Research
ABGR XI International Risk management and Insurance Seminar “Introduction to Risk Management” ALARYS Latin American Risk Management Foundation (FUNDALARYS)
Health Services Organization and Management HSA 500 The Pharmaceutical Industry Williams, S. J., & Torrens, P. R. (2008). Introduction to Health Services.
Introduction to Enterprise Risk Managment Types of Risk Impact of Risk ERM –Importance of ERM –ERM Options –Risk Profiles & Portfolios –ERM Valuation Credit.
S5: Internal controls. What is Internal Control Internal control is a process Internal control is a process Internal control is effected by people Internal.
1  The objective of operational risk management is the same as for credit, market and liquidity risks that is to find out the extent of the financial.
CAS Spring Meeting June 2007 Introduction to ERM …The Measurements, Quadrants, Tools, and Solutions Prof. Mark C. Vonnahme Fox Family Clinical Professor.
Overview Scope Deliverables
PIC EU-28 Conference Paris, 26 – 27 November 2015 PIC An EU Approach Assurance Maps An Introductory workshop Nathan Paget United Kingdom.
1 COSO ERM Framework Update Our Next Challenge and Opportunity September 2015.
Dolly Dhamodiwala CEO, Business Beacon Management Consultants
Enterprise Risk Management & IT Implications BADM 559 Megan Kasbohm.
Trinity Industries, Inc. FEI Presentation May 31, 2012.
Company LOGO Chapter4 Internal control systems. Internal control  It is any action taken by management to enhance the likelihood that established objectives.
Lecture 5 Control and AIS Copyright © 2012 Pearson Education 7-1.
An Overview on Risk Management
اطار الرقابة الداخلية و فقا للجنة دعم المنظمات COSO
Prepared by: Yazan Metwalli(148371) Moyad Habiballah(137535)
Understanding the current Public Sector landscape from an risk management point of view Applying the ethical responsibility to the Triple Bottom-line:
Operational Risk Management
Presentation transcript:

ERM and the Pharmaceutical Industry

Risk  An innate part of every aspect of life, and the business environment is of no exception  Severity, both in terms of impact and likelihood, of risks are increasing in general due to the influence of globalization  Systematic risks › General economic conditions, competition, regulation  Industry specific risks › Ex: Political tensions and their impact on the oil industry

Pharmaceutical Industry  More than ever before, advances in healthcare are reaching new horizons never before believed to be possible  Perhaps the riskiest industry due to its unique environment › Intense competition to create new drugs and from generic drug manufacturers › Government regulation -- FDA Drug Approval Process › Patent protection issues › Drug failure › Litigation exposure

FDA Approval Process  Food and Drug Administration (FDA) regulates pharmaceuticals in the United States › Drug safety, quality standards, labeling and warnings, etc.  The drug approval process is extremely complex › Preclinical laboratory testing (often involves experimentation with animals) › Three phases of human testing › Post market monitoring

FDA Approval Process › Graphical Depiction › Statistical Reality › For every 5,000 compounds that enter preclinical testing, only about 5 reach first phase of human testing › Of the 5 that make it to human testing, only roughly 1 will achieve approval

COSO’s ERM Framework  Enterprise Risk Management (ERM) involves the procedures and methods used by an organization to assess, manage, and mitigate risk  Committee of Sponsoring Organizations of the Treadway Commission (COSO) developed a widely used ERM framework during a period of widespread corporate scandals

COSO’s ERM Framework  ERM Objectives (4) › strategic objectives › operations objectives › reporting objectives › compliance objectives  ERM Components (8) › internal environment › objective setting › event identification › risk assessment › risk response › control activities › information and communication › monitoring

Application of ERM to Pharmaceutical Companies  Internal environment is a vital component in terms of protecting an organization’s sensitive research and development information › Corporate culture built upon high ethical standards › Proactive measures to hire individuals with integrity › Adequate and effective internal controls

Conclusion  Clearly, pharmaceutical companies face a myriad of risk factors › Intense competition and government regulation (FDA approval process)  However, ERM is an effective way for pharmaceutical companies to manage their risks › Reduce exposure to losses due to competition, drug failure, litigation, etc.