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DTSTART;TZID=America/Toronto:20201002T080000
DTEND;TZID=America/Toronto:20201002T170000
DTSTAMP:20260427T172259
CREATED:20201002T211127Z
LAST-MODIFIED:20230119T202735Z
UID:16482-1601625600-1601658000@aapswebsite.schools.consulting
SUMMARY:Introduction to Drug Safety Workshop
DESCRIPTION:Drug Safety and Pharmacovigilance 101	\n	\n		\n	\n\n\nLive interactive and instructor led\n\nOverview\nThe Introduction to Drug Safety module provides the basics of pharmacovigilance\, its regulation throughout all stages of the drug life cycle\, and the foundation knowledge required to work day-to-day in clinical safety and the pharmacovigilance industry. \nThe module includes the historical overview of drug safety legislation\, from the beginning to the current international standards; basic definitions and tools of adverse events and adverse drug reactions recording\, assessment and reporting\, as well as pharmacological mechanics of drug safety. The second part of the module provides the basic skills of pharmacovigilance documentation management\, including safety reports\, reference safety information\, and post-marketing labeling preparation and handling. \nFeatured Topics\n\n	Drug Safety and Pharmacovigilance: The Basics and History\n	Terminology\, Definitions\n	Adverse drug reactions: severity and seriousness grading\, causality assessment\, and reporting\n	International standards of drug safety surveillance (ICH guidelines and US standards).\n	Drug safety reports: Individual Case Safety Reports and Expedited Reporting\n\nLearning Objectives\nUpon completion of this course\, participants should be able to: \n\n	Discuss the history\, principles\, and regulatory environment of drug safety\n	Define terms used in day-to-day pharmacovigilance work\n	Explain the assessment of seriousness\, expectedness\, and causality of adverse events\n	Explain pharmacovigilance methodology and documentation \n	How to perform drug safety reports\n\nWho Should Attend\nProfessionals working in the area of: \n\n	Clinical safety & pharmacovigilance\n	Clinical research\n	Regulatory affairs\n	Medical writing\n	Marketing\n\nCertificate of Attendance and Course Material
URL:https://aapswebsite.schools.consulting/event/introduction-to-drug-safety-workshop
CATEGORIES:Onsite Training
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DTSTART;TZID=America/Toronto:20201002T080000
DTEND;TZID=America/Toronto:20201002T170000
DTSTAMP:20260427T172259
CREATED:20201002T211955Z
LAST-MODIFIED:20201005T153030Z
UID:16489-1601625600-1601658000@aapswebsite.schools.consulting
SUMMARY:Good Pharmacovigilance Practice Workshop
DESCRIPTION:Good Pharmacovigilance Practice Workshop	\n	\n		\n	Register online\n\n\nDates Available\nDecember 17\, 2020 \nTime\n9:00 a.m. – 5:00 p.m. \nCost\nCAD $685.00 + HST \nLocation\nOnline \n\n\n\n\nLive interactive and instructor led\n\nOverview\nAn effective and efficient pharmacovigilance system is essential to protect the wellbeing of patients\, to meet regulatory requirements and to protect the commercial interests of organizations which market medicinal products or sponsor clinical trials. \nThe aim of this course is to facilitate the delegates contribution to improving the efficiency and effectiveness of the pharmacovigilance system. It will promote a clear understanding of the regulatory requirements and explore best practice in discharging legal and commercial responsibilities for marketing medicinal products for human use. \nFeatured Topics\n\nIntroductions\, overview of the course. What do we need to know to succeed? Pharmacovigilance planning.\nThe Regulatory Framework\nAssessing and Processing Adverse Events\nCollection\, collation and evaluation of individual case safety reports. Quality management of the process.\nData Management in Pharmacovigilance\nUsing IT to support the PV process\nInformation Management\nPractical exploration of event assessment\, processing\, follow-up and documentation.\nPharmacovigilance and the Interventional Clinical Trial\nInformation flow and the responsibilities of the sponsor\nRoles and Responsibilities of the Qualified Person for\nWhat is a signal? Regulatory requirements.\nHow is signal detection and evaluation conducted? Qualitative and quantitative methods of signal detection.\n\nLearning Objectives\nUpon completion of this course\, participants should be able to:\n\n	Appreciate the wide scope of company responsibilities\n	Develop confidence in handling quality issues within the pharmacovigilance system\n	Discuss and develop ideas\n	Solve specific problems\n\nWho Should Attend\nProfessionals working in the area of: \n\n	Qualified Persons responsible for Pharmacovigilance\n	Pharmacovigilance Scientists\n	Auditors\n	Regulatory Affairs Professionals\n	Medical Assessors\n	Marketing Managers\n	Statisticians\n	Information Scientists\n\nCertificate of Attendance and Course Material\n\nAll participants will receive a certificate of attendance upon completion of the course.\nThe participants will be receiving specially prepared course manual.
URL:https://aapswebsite.schools.consulting/event/good-pharmacovigilance-practice-workshop
CATEGORIES:Onsite Training
ATTACH;FMTTYPE=image/jpeg:https://aapswebsite.schools.consulting/wp-content/uploads/1366x400-Desktop-workshops.jpg
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BEGIN:VEVENT
DTSTART;TZID=America/Toronto:20201002T080000
DTEND;TZID=America/Toronto:20201002T170000
DTSTAMP:20260427T172259
CREATED:20201002T212629Z
LAST-MODIFIED:20210423T171540Z
UID:16491-1601625600-1601658000@aapswebsite.schools.consulting
SUMMARY:Pharmacovigilance Regulations and Good Pharmacovigilance Practices Workshop
DESCRIPTION:Pharmacovigilance Regulations and Good Pharmacovigilance Practices Workshop	\n\n\n\nLive interactive and instructor led\n\nOverview\nDrug Safety has significantly evolved in the last 2 decades. Regulatory Authorities including Health Canada have focused on Good Pharmacovigilance Practices (GVP) pertaining to the Pharmaceutical Industry. There is also an emphasis on benefit-risk evaluation\, and risk management rather than passive drug safety surveillance alone. Regulatory compliance including requirements for Annual Safety updates (PSUR/PBRER)\, may also include a necessity for a Pharmacovigilance (PV) plan\, and Risk Management Plan (RMP)\, based on the benefit-risk profile of a drug. Recent changes in the Canadian Food and Drug Act (Bill C-17) have provided Health Canada with significantly more authority to protect Canadians from unsafe drugs\, which include strengthen oversight of pharmaceuticals and medical devices\, and authority to act on safety issues (including post-marketing requirements\, labelling modification\, product recall\, stop-sales\, or other corrective action) including non-compliance (with significant fines). \n\nHealth Canada implemented an inspection program for Good Pharmacovigilance Practices (GVP) in 2004. The program is intended to verify that Market Authorization Holders (MAH) and importers\, meet the requirements of sections C.01.016 to C.01.020\, C.08.007 (h) and C.08.008 (c) of the Food and Drug Regulations. \n\nGuidance documents released by Health Canada help to ensure uniform application of these requirements by the industry and include: 1) Good Pharmacovigilance Practice (GVP) Guidelines (GUI-0102) (which outlines the interpretations of the regulations with respect to the adverse drug reaction and post-approval reporting requirements)\, 2) the revised Risk Classification of GVP Observations (GUI-0063)\, and 3) the Inspection Strategy for GVP for Drugs (POL-0041). \n\nThe European Medicines Agency is the medicines regulatory authorities in EU Member States. They cover medicines authorized centrally via the Agency as well as medicines authorized at national level. The European Medicines Agency (EMA) have provided a comprehensive document on GVP as a set of measures to facilitate the performance of pharmacovigilance in the European Union (EU). It is the best benchmark for GVP internationally. It contains 16 modules covering major pharmacovigilance processes. \nAbstract\nThis course\, will be cover the Health Canada regulations for Drug Safety and related guidance documents\, along with selected EMA GVP documents. Participants will obtain a core understanding of compliance requirements for Good Pharmacovigilance Practices. \n\nA one-day comprehensive & interactive seminar\, covering the following items:\n\n\nSections of the Health Canada Food and Drug Act pertaining to Drug Safety activities\nNew Regulations introduced in Canada (Bill C-17)\nHealth Canada Guidelines GUI-0102\, GUI-0063\, and POL-0041\nSelected EMA GVP documents including:\n\nPharmacovigilance systems and their quality systems\nPharmacovigilance system master file\nPharmacovigilance inspections\nPharmacovigilance audits\nRisk Management systems\nManagement and reporting of adverse reactions to medicinal products\nPeriodic safety update report\nPost-authorizations safety studies\n\n\n\nWho should attend:\n\nDrug Safety Associates and Managers\nClinical Research Associates and Managers involved in Phase IV studies\nContract Research Organizations with a drug safety role\nPersonnel involved in Medical Information Services\nCompany personnel initiating a Drug Safety team or having concerns regarding ADR\n\nCertificate of Attendance and Course Material\n\nAll participants will receive a certificate of attendance upon completion of the course.\nThe participants will be receiving specially prepared course manual.
URL:https://aapswebsite.schools.consulting/event/pharmacovigilance-regulations-and-good-pharmacovigilance-practices-workshop
CATEGORIES:Onsite Training
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DTSTART;TZID=America/Toronto:20201006T080000
DTEND;TZID=America/Toronto:20201006T170000
DTSTAMP:20260427T172259
CREATED:20201006T163617Z
LAST-MODIFIED:20201006T163617Z
UID:16514-1601971200-1602003600@aapswebsite.schools.consulting
SUMMARY:The Challenges of Change Control: Its Implementation and Maintenance Workshop
DESCRIPTION:The Challenges of Change Control: Its Implementation and Maintenance Workshop	\n	\n		\n	Register online\n\n\nDates Available\nDecember 4\, 2020 \nTime\n9:00 a.m. – 5:00 p.m. \nCost\nCAD $585.00 + HST \nLocation\nOnline \n\nDistinguished Faculty\nMr. Kenneth Christie - Chief Operating Officer - VTS Consultants\n\n\nLive interactive and instructor led\nMr. Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants\, Inc located in Amhesrt\, MA. Specifically\, his responsibilities include quality system auditing\, GMP training\, and serving as a subject matter expert for aseptic manufacturing processes\, medical devices\, APIs and solid dosage processing equipment\, utilities\, and systems on a global basis. Mr. Christie also performs vendor audits\, site pre-approval inspections and assists clients with addressing and correcting regulatory observations. \n\nMr. Christie was the Validation Manager at Parke-Davis’ Sterile Products Facility where he was involved in the review and approval of all facilities\, equipment\, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA)\, corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products. \n\nMr. Christie is a speaker and trainer for several professional organizations in the US\, Canada\, Europe\, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally\, Mr. Christie serves as a member of the ISPE Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member. \n\nHe possesses a BS degree in Biology from Shippensburg State University (PA) and an Executive MBA degree from Michigan State. \nCourse Description\nWithin the regulated industries of pharmaceuticals\, medical devices and biotechnology\, the quality system requirements expects companies to document\, assess\, implement and then evaluate any and all changes made to equipment\, utilities\, systems and documents that impact GXP operations. One only has to look at the most common deficiencies cited by regulatory auditors to know that this activity continues to cause companies to struggle with how to implement and then manage such a program. Challenges faced include when to implement change control\, the proper documentation of changes\, the assessment of the overall impact to qualified systems and then how to assure the effectiveness of the changes made. A second challenge faced by manufacturing facilities is the review and approval of such changes before they are implemented and the larger the company\, the greater the pressures not to delay such changes. \n\nThis course will look at the following items through a combination of classroom instruction\, group activities\, handouts and actual case studies to help illustrate the main points of an effective change control program. Topics will include the regulatory requirements for change control\, the main topics to include in a change control SOP and examples of a change control form to use for the documentation and evaluation of changes. In addition\, the course will use actual class examples of various changes and then perform an evaluation of how to assess the change and its potential impact. Handouts will include examples of a change control SOP and form used for the documentation of proposed changes with the opportunity to openly discuss questions and make suggestions. Challenges faced by companies to maintain such systems will also be discussed along with the control of changes made to controlled documents. \nTopics to be covered\n\nReview of regulatory requirements for change control by both the FDA and Health Canada\nReview of the type of changes that can occur to equipment\, utilities\, systems\, facilities\, and documents.\nDiscuss when change control should be implemented and cases where it is not necessary.\nReview topics to be considered during impact assessment of changes...such as training\, procedures\, drawings\, regulatory issues\, third party customer impact\, additional testing needs\, safety issues\, etc.\nDiscuss challenges faced by industry delays in implementation\, review process\, capturing all changes proposed\, emergency changes\, evaluation of effectiveness of changes made.\nClass exercise discuss an actual change and how the assessment process would work.\nReview the format for both a change control SOP and form for its documentation.\nDiscuss an example of an actual SOP and form used for change control. Critique for both good\, poor or missing items.\nReview typical questions raised by auditors during inspections regarding change control practices.\nDiscuss change control as it applies to third party customers and vendors. What are the responsibilities of both parties and issues to address in quality agreements.\n\nQuestions and answer period upon course completion\nDepartments to which this course would apply\n\n	Regulatory\n	QA/QC\n	Manufacturing\n	Engineering\n	Validation\n	Packaging\n	Suppliers and/or Vendors\n	Third party customer representatives\n	Management\n\nBenefits to be gained\nThe expectation for an effective change control program to assure the validated state of equipment\, utilities and facilities is a basic premise found in the quality system regulations (QSR). In addition\, change control is a routine area of focus by both the FDA and Health Canada inspectors. Knowing what to do and the management of such a program is one of the fundamental requirements to successfully get through a quality system audit. This course will give attendees the opportunity to review examples of change control forms\, what to include in applicable procedures and case studies that will help highlight various points covered.\n\nCertificate of Attendance and Course Material\n\nAll participants will receive a certificate of attendance upon completion of the course.\nThe participants will be receiving specially prepared course manual.
URL:https://aapswebsite.schools.consulting/event/the-challenges-of-change-control-its-implementation-and-maintenance-workshop
CATEGORIES:Onsite Training
ATTACH;FMTTYPE=image/jpeg:https://aapswebsite.schools.consulting/wp-content/uploads/1366x400-Desktop-workshops.jpg
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