Data Integrity: FDA/EMA Requirements and Implementation

1. 2-Day Virtual Seminar by Ex-FDA Director Data Integrity: FDA/EMA/TGA Requirements and Implementation By: David L. Chesney, Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director) Dates: July 14-15, 2021 (11:00 AM to 5:00 PM EDT) Location: Virtual Training Through WebEx Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online. SPEAKER David L. Chesney,Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director) His career includes 23 years with the FDA and over 21 years in GMP and GCP consulting worldwide. In his consulting practice, Mr. Chesney helps clients prevent quality and compliance problems through proactive assessment and planning, and when necessary, with remediation planning and health regulatory authority communications. In 1991, he was appointed the District Director, FDA San Francisco District Office, where he served until joining PAREXEL in 1995. For 19 years, he led the Strategic Compliance Consulting group, and also personally provided regulatory enforcement related consulting services to the pharmaceutical, medical device and biologics industries, plus technical assistance to legal counsel in FDA regulatory matters. Mr. Chesney has a bachelor's degree and postgraduate credits in biology from California State University, Northridge and San Diego, and received a Certificate in Health Care Compliance from Seton Hall University School of Law. Until recently, he served as Vice President, Strategic Compliance Services for PAREXEL Consulting, a business unit of PAREXEL International LLC. Prior to joining PAREXEL Consulting in 1995, Mr. Chesney served 23 years with the FDA, where he advanced from Investigator to Supervisory Investigator and Director, Investigations Branch, working in the Boston, Seattle and Philadelphia District Offices. LEARNING OBJECTIVES Upon completing this course participants should:  Understand the meaning of the term “data integrity” and the importance of the acronym “A.L.C.O.A.” to regulatory agencies  Understand the difference between innocent lapses and deliberate wrongful conduct  Be aware of some of the key historical events that form the basis for regulators’ concerns about data integrity  Understand some of the common motivations for deliberate wrongful conduct that results in data falsification  Understand the impact of the use of computer systems on the maintenance of data integrity, and what types of system controls are mandated by various agencies around the world  Be aware of the possible business and regulatory consequences of noncompliance  Understand the important steps to take to prevent, detect and react to data integrity problems www.complianceonline.com 6201 America Center Drive, Suite 240 San Jose, CA 95002 | Fax: 650-362-2367 | Email: customercare@complianceonline.com | Toll Free: +1-888-717-2436

2. 2-Day Virtual Seminar by Ex-FDA Director 02 DATA INTEGRITY: FDA/EMA/TGA REQUIREMENTS AND IMPLEMENTATION COURSE DESCRIPTION The integrity of data generated in support of marketing authorizations and in GMP, GCP and GLP regulated activities is foundational to sound decision making and regulatory compliance. Data integrity lapses are among the most serious concerns that pharmaceutical regulatory authorities have. Enforcement penalties can be severe from a business standpoint, and in extreme cases can even impact individuals who are held responsible for the occurrence of data integrity problems. In recent months the topic of data integrity has been in the forefront of concern among worldwide pharmaceutical regulatory agencies. The FDA, EMA, TGA and others have published guidelines setting forth their requirements and expectations for the maintenance of data integrity, as has at least one leading industry organization (PDA). The use of computer systems in virtually every aspect of data acquisition, storage, and analysis can help preserve data integrity and reduce or eliminate many errors, but the same technology can also create unique problems that must be prevented and managed. In this two day workshop conference you will learn the meaning of "data integrity"; be exposed to some of the history that influences current regulatory requirements and expectations; see a comparison of the current guidance from leading regulatory agencies including the FDA, EMA, TGA and key industry associations such as the Parenteral Drug Association; see a recap of the enforcement options available to the FDA, including imposition of the Application Integrity Policy (also known as the "Fraud Policy"); discuss and learn from selected current real-life case histories; and hear advice for how to prevent, detect and react to data integrity problems so as to minimize business and regulatory risk. AGENDA Day One (11:00 AM - 5:00 PM EDT) Day Two (11:00 AM - 5:00 PM EDT) 11.00 AM: Session Start  Welcome and time for questions from day one  Introductions Instructor Participants Determination of participant’s desires and expectations for the session  Comparison of current data integrity guidance documents from regulators and industry sources FDA EMA PDA Code of Conduct (industry viewpoint) PIC/S (Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme)  Introduction to data integrity Defining data integrity “ALCOA” acronym meaning Criticality of data integrity to “GXP”-governed activities “Fraud” versus innocent conduct that can lead to data integrity lapses Examples from other industries (automobiles, finance, etc.)  Consequences of noncompliance FDA: Application Integrity Policy Disqualification of Clinical Investigators Civil and criminal sanctions Case study: Consent decree imposed on a company outside the US; implications of extraterritorial jurisdiction asserted by FDA EMA/MHRA Other agencies Business consequences – Case study examples  Historical Perspectives The American “Generic Drug Scandal” of the late 1980s- early 90s and its consequences Expansion of computer system use in GXP operations and its impact Emergence of current worldwide concern among regulators  Motivators behind deliberate wrongful conduct “Achieve gain” “Avoid pain” Managing to avoid the “Law of Unintended Consequences”  Steps to take to prevent, detect and react to data integrity problems Fundamentals of good documentation practice Retention of true copies in lieu of originals – is it allowed, and if so, what are the expectations? Signs you may have a data integrity problem How to react if you suspect deliberate falsification Involving legal counsel and external expert assistance Considerations for voluntary disclosure to regulators (with concurrence of legal counsel)  Computer system issues Audit trails Changes to data Metadata implications for data integrity Computer System Controls required by the US and EMA FDA Case studies of data integrity issues GMP GCP GLP  Questions, general discussion, summary and wrap up WHO WILL BENEFIT This course is designed for people who generate, review and archive data in support of marketing authorization applications to health regulatory agencies such as the FDA, EMA and TGA, and those who generate, review and archive GMP, GCP and GLP data in manufacturing, clinical trials and pre-clinical testing laboratories. The following personnel will benefit from the course:  Production personnel  Senior Quality and Regulatory Affairs managers  Laboratory Managers  Clinical and Manufacturing Quality professionals  Clinical Operations Personnel  Regulatory Affairs professionals  Drug Safety (Pharmacovigilance) Personnel  Compliance professionals  R&D and Quality Control Scientists  In House Legal Counsel  Quality auditors  Production supervisors  Manufacturing personnel www.complianceonline.com 6201 America Center Drive, Suite 240 San Jose, CA 95002 | Fax: 650-362-2367 | Email: customercare@complianceonline.com | Toll Free: +1-888-717-2436

3. 2-Day Virtual Seminar by Ex-FDA Director DATA INTEGRITY: FDA/EMA/TGA REQUIREMENTS AND IMPLEMENTATION Registration Form................................................................................................ ...................... REGISTER WITH NO WORRIES Registration Information:     Register Online. Use your American Express, Visa or MasterCard. Get your group to attend the seminar at a discounted price call +1-888-717-2436. Call Toll Free: +1-888-717-2436 (USA) or Fax your PO: 650-362-2367 Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to: ComplianceOnline (MetricStream, Inc), 6201 America Center Drive, Suite 240 San Jose, CA 95002. Please fill this form with attendee details and payment details and fax it to +1-650-362-2367  Terms & Conditions Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us at +1-888-717-2436 (USA) or email us at customercare@complianceonline.com Note: In view of Coronavirus situation and travel advisory issued, ComplianceOnline will waive off all cancellation charges for the registrations till May 31, 2021 Cancellations and Substitutions - In-person Seminars: Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over. In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice. Cancellations and Substitutions - Virtual Seminars & Webinars: Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice. Seminar Topic: ................................................................................................................................................................................................................................................ The Drug Development Process from Concept to Market Date & Location: ............................................................................................................................................................................................................................................... July 14-15, 2021 (11:00 AM to 5:00 PM EDT) Attendee Details: Name Title Email Attendee 1 Attendee 2 Attendee 3 Attendee 4 Email address (so you can receive order acknowledgements, updated news, product information and special offers) Payment Options Company Information Check enclosed, payable in U.S. funds to ComplianceOnline (MetricStream, Inc.) Organization ....................................................................................... Charge to: Visa MasterCard American Express ............................................................................................................ Credit card no. ................................................................................................................... Address .............................................................................................. 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Print name.......................................................................................................................... Phone ........................................... Fax .............................................. Bill me/my company $ .................................................................................................. Purchase order # ............................................................................................................... (Payment is required by the date of the conference.) Please fill this form with attendee details and payment details and fax it to +1-650-362-2367 www.complianceonline.com 6201 America Center Drive, Suite 240 San Jose, CA 95002 Ph: +1-888-717-2436 | Fax: +1-650-362-2367 www.complianceonline.com 6201 America Center Drive, Suite 240 San Jose, CA 95002 | Fax: 650-362-2367 | Email: customercare@complianceonline.com | Toll Free: +1-888-717-2436