elearning Catalog DIAglobal.org/eLearning

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1 elearning Catalog DIAglobal.org/eLearning

2 Continuing education DIA s Continuing education program has been approved by a wide range of leading accrediting bodies that oversee the awarding of continuing education credits. DIA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. DIA has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET). DIA has been reviewed and approved as a provider of project management training by the Project Management Institute (PMI). Continuing education credits are offered for some elearning modules. Visit DIAglobal.org/CE for more details on Continuing education. Disclosure Policy: It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials. to obtain continuing education credit for a module (if applicable), you must receive a passing score of 80% or better on the module exam. group Discounts and Licensing DIA offers discounted rates to organizations interested in purchasing elearning modules for 10+ users. users will be able to complete the modules on the DIA Learning management System (LmS) or organizations can choose to license the modules to host on their LmS. To request a proposal for multiple users, contact elearning@diaglobal.org. 2 elearning Catalog

3 table of Contents DIA has partnered with the following elearning providers: Drug SAfety elearning ProgrAm Introduction to Drug Safety... 6 Drug Safety regulatory requirements... 6 Premarketing Clinical trial Safety... 6 Postmarketing Safety management... 7 Basics of Signal Detection and Pharmacoepidemiology Safety Audits and Inspections... 7 medical CommunICAtIonS elearning CertIfICAte ProgrAm Crisis management... 8 Database management... 8 Literature evaluation... 8 Literature Searching... 8 medical Inquiries... 9 medical Writing... 9 Product Labeling... 9 regulatory Issues... 9 Statistics for medical Communications Professionals... 9 CLInICAL research Aspects of regulatory history A tour of fda A tour of health Canada A tour of health europe Basics of Clinical trials Bioresearch monitoring Program (BImo): Introduction Clinical Development Process: Investigational Product, Plan, and Data management Clinical Investigator elearning Program Clinical Investigator: module 1 Study Preparation and Initiation Clinical Investigator: module 2 Conducting the Study Clinical trial Audits and Consequences of non-compliance Computerized Systems Inspections in the medical Device Industry For more information, visit DIAglobal.org/eLearning 3

4 table of Contents Computerized Systems Inspections in the Pharmaceutical Industry ethical review Boards ethics as the foundation to Clinical research european union Clinical trials Directive good Clinical Practices (gcps) for new Product Investigations good Laboratory Practices (glps) gxps hipaa the Impact on Clinical research...16 Informed Consent Investigational Product Development ISo 14155: obligations of Sponsors and monitors for medical Device trials Laboratory Specimens for Clinical research medical Device Safety reporting overview of the Clinical research Process Part 11: electronic records; electronic Signatures Part 11: electronic records and Signatures Application Protection of human Subjects in Clinical trials Selecting and managing Clinical Contract research organizations (Cros) good manufacturing PrACtICeS Awareness of fda Inspections for Pharmaceutical manufacturers Biotechnology: An overview of Compliance Considerations Change Control gmp Principles of SoPs gmp updates enforcement Changes at the new fda gmps for API Bulk manufacturers gxps Introduction to gmps Key Concepts of Process Validation orientation to gmp Compliance Part 11: electronic records; electronic Signatures Principles of good Documentation understanding Post-Approval Changes regulatory AffAIrS Access to unapproved Drugs through Compassionate use how to gain Approval to market generic medicinal Products in the usa how to maintain marketing Approvals in europe for Centrally Authorised Products how to register a new Drug in the usa how to register medicinal Products through the Centralised Procedure how to register medicinal Products through the Decentralised Procedure how to register medicinal Products through the mutual recognition Procedure Introduction to Japanese Institutions and regulatory Authorities Introduction to the european union Institutions and regulatory Authority Introduction to the International Conference on harmonisation (ICh) elearning Catalog

5 Introduction to us Institutions and regulatory Authority (fda) meeting opportunities with regulatory Agencies orphan Drugs in the usa, european union, and Japan overview of the CtD and ectd Pharmacokinetics and Pharmacodynamics in Drug registration registration of monoclonal Antibodies regulatory requirements for the Conduct of Clinical trials in europe regulatory requirements for the Submission of Investigational new Drug Applications the regulatory Development of a Drug Variations to marketing Authorisations in europe ADDItIonAL elearning modules Basics of the Advamed Code Basics of the PhrmA Code eucomed guidelines on Interactions with health Care Professionals foreign Corrupt Practices Act global Anti-bribery Introduction to medical Device health Care Compliance medical Device Safety reporting Drug Development & Life Cycle management elearning Program module 1: overview of Drug Development module 2: Discovery and Preclinical testing Phases module 3: Phase 1 Studies module 4: Phase 2 Studies module 5: Phase 3 Studies and regulatory review...37 module 6: Phase 4 & Life Cycle management...37 PurChASe multiple ul elearning modules At one time AnD SAVe one to two modules... $99 each three to four modules... $89 each five to nine modules... $80 each 10 + modules... $65 each QueStIonS? Linda Belmont, DIA P: e: Linda.Belmont@DIAglobal.org For more information, visit DIAglobal.org/eLearning 5

6 Drug Safety elearning Program Drug safety is a primary concern throughout the health care product development life cycle. to help organizations address the challenges and ensure compliance with regulations, DIA developed a customized, in-depth Drug Safety elearning Program to provide the knowledge you and your staff need. IntroDuCtIon to Drug SAfety get information on the legal basis for safety reporting, including a historical perspective; basic definitions and tools; the mechanics of drug safety and pharmacovigilance; reference safety information provided by the Investigator s Brochure and postmarketing labeling; and evaluation of seriousness, expectedness, and causality. Drug Safety: The Basics Terminology A Typical Company Safety Unit Tracking a Case from Start to Finish Assessing Cases Reference Safety Information: The Investigator Brochure and Postmarketing Labeling Drug SAfety regulatory requirements this module includes harmonization initiatives, key us and eu regulations, the roles that ICh and CIomS play in drug safety regulations, good clinical and pharmacovigilance practices, and standard operating procedures (SoPs) that support drug safety. Harmonization Initiatives Important US Regulations Important EU Regulations Good Clinical and Pharmacovigilance Practices Standard Operating Procedures PremArKetIng CLInICAL trial SAfety get information about safety and ethical safeguards in place to protect human subjects in clinical trials: informed consent, institutional review boards and ethics committees, and data safety monitoring boards, plus more. Informed Consent Institutional Review Board/Ethics Committee Individual Case Reporting Aggregate Reporting Risk Assessment Premarketing Review of Safety Data in an Application Data and Safety Monitoring Boards Purchase all Six modules and Save 20%. Save 10% on the purchase of two to five modules. to purchase, visit DIAglobal.org/safetyelearning group Discounts and Licensing Available. See page 2 for more information. 6 elearning Catalog

7 PoStmArKetIng SAfety management get the framework and details around drug safety monitoring requirements for drugs after they are approved for marketing. this module provides information about spontaneous reporting, aggregate reporting, risk assessment, benefit-risk management, risk management plans, and risk evaluation and mitigation strategies (rems). Spontaneous Case Reporting Aggregate Reporting Benefit-Risk Assessment Risk Management Plans Risk Evaluation and Mitigation Strategies Postmarketing Case Studies BASICS of SIgnAL DeteCtIon AnD PhArmACoePIDemIoLogy get an introduction to signal detection in pharmacovigilance. the module covers safety signal basics, safety databases, data mining and the mathematics of drug safety, principles of pharmacoepidemiology, and signaling regulations. Safety Signal Basics and Regulations Data Mining Safety Databases Mathematics of Drug Safety Pharmacoepidemiology SAfety AuDItS AnD InSPeCtIonS get an overview about audits and inspections, with specific focus on the us food and Drug Administration (fda), european medicines Agency (ema), and the uk s medicines and health care Products regulatory Agency (mhra) inspections. the module also discusses common inspection findings, how companies should respond to an inspection, and practicalities of inspections and audits. Types and Scope of Audits and Inspections Common Inspection Findings Responding to an Inspection Corrective and Preventative Action Plan Program developed by For more information, visit DIAglobal.org/eLearning 7

8 medical Communications elearning Certificate Program CrISIS management get a refresher on the principles of managing a crisis. It will focus on how to define the various types of crises and the methods to manage them, as well as provides you with a brief background on drug-recall terminology, definitions, and regulations. Crisis communications Crisis management Drug-recall terms and regulations DAtABASe management get an overview of the utility and application of computerized database management systems used by medical communications departments and pharmaceutical companies. Medical communications Computerized database management Computerized database design LIterAture evaluation effectively evaluate scientific literature so you can identify and provide relevant and reliable information to medical professionals regarding the use of a particular drug. the module will help you evaluate research on a drug to determine the applicability and reliability of the research information. Scientific literature evaluation Medical communications Drug research analysis LIterAture SeArChIng this module is designed to help you effectively search for medical literature in order to satisfy requests for information from all stakeholders including consumers, health care professionals, and internal colleagues. Medical literature search Copyright basics Commercial and government databases use medical WrItIng this module is designed to familiarize industry-based drug information specialists with the preparation of written responses to specific drug information questions. Industry regulatory guidelines Editing and writing abstracts Principles of concise writing Purchase all nine modules and save 20%. Purchase two or more modules and save 15%. to purchase, visit DIAglobal.org/MedComm-eLearning group Discounts and Licensing Available. See page 2 for more information. 8 elearning Catalog

9 Program developed by Complete all nine modules, receive a DIA medical Communications Certificate medical InQuIrIeS this module is designed to introduce the medical communications professional to fielding questions, retrieving information, and delivering responses verbally in the pharmaceutical industry. While much of this information is general, it is provided for common understanding of terminology, various situations and approaches to providing medical information with great customer service. Handling consumers concerns by phone Understanding the needs of the customer Evaluating the sources of information available when preparing a response Learning best methods of record-keeping Knowing which situations call for a written or spoken response ProDuCt LABeLIng this module is designed to familiarize you with the components and structure of the prescription drug label and the medication guide, plus all pertinent regulatory and legal requirements with which they must comply. this module also provides historical background and perspective on the events that have culminated in current food and drug laws. FDA regulation of drugs Prescription drug labels Medication guide structure and use regulatory ISSueS understand the fda s jurisdiction over the dissemination of information about drug products and the governing regulations and guidance documents. Law enforcement and prescription drugs Prescription drug advertising FDA role in drug approval and labeling StAtIStICS for medical CommunICAtIonS ProfeSSIonALS you will learn how to apply statistical concepts when evaluating literature, identify strengths and weaknesses in study design, and detect potential bias in the presentation of statistics. the goal of this module is not to turn you into a statistician. It places less emphasis on how to perform specific statistical tests and more emphasis on understanding what you are reading when you are evaluating medical literature. the module aims to make you comfortable with the language of statistics so you can ask questions and discuss issues with your statistician colleagues. Evaluation of statistical data in medical literature Assessing the strengths and weaknesses in Detection of bias in the presentation of statistics study designs For more information, visit DIAglobal.org/eLearning 9

10 Clinical research ASPeCtS of regulatory history get an overview and summary of the regulatory history and requirements by the food and Drug Administration (fda) and International Conference on harmonisation (ICh), which are necessary to ensure proper and successful clinical trial execution. this module is also designed to take you through some of the history behind today s system of drug and device development. It is important to provide you with this perspective so that you can recognize how the industry and the fda have evolved. review of (ICh) will also provide you with an understanding of its impact on the industry form a global perspective. Setting standards Organizations Regulations Guidelines A tour of fda fda-regulated industries must work closely with fda to comply with industry regulations and create safe and effective products. But how well do your employees know FDA? A Tour of FDA serves as an excellent introduction to the organizational structure of fda and gives an overview of the different enforcement actions available to this critical agency. take a virtual tour of fda, learning about the function of each Center along the way. Afterwards, explore different actions the Agency may take in order to achieve compliance. FDA background Organizational structure of the FDA Office of the Commissioner Office of Regional Affairs Enforcement actions Informal enforcement Formal enforcement Seven main program Centers A tour of health CAnADA this special tour introduces you to health Canada s mission and organization. After the brief introduction, the tour will focus on the health Products and food Branch (hpfb) of health Canada, which directly affects pharmaceutical manufacturers. After completing this module, you will be familiar with the major branches of health Canada, the hpfb, and its Directorates. In addition, you will be able to identify the unique roles and responsibilities of the three hpfb Directorates that most directly affect the pharmaceutical industry. Mission Organizational structure of Health Canada HPFB Therapeutic Products Directorate (TPD) Biologics and Genetic Therapies Directorate (BGTD) Role of the HPFB Inspectorate 10 elearning Catalog

11 Best training yet. Very informative. Easy to follow. A tour of health europe the system in europe for ensuring safe, effective, and high-quality medical products is composed of national authorities in individual countries as well as bodies in the european union and the Council of europe. After completing this module, you will know the organizations that oversee the health industry in europe and the bodies in those organizations that affect pharmaceutical companies. In addition, you will know the ways health products can be approved for sale to the public and the system for reporting and tracking defective products. Organizations overseeing the health industry in Europe How the EU works to ensure the health of Europeans The role of the Council of Europe Market authorization Pharmacovigilance BASICS of CLInICAL trials A Module This module covers the basics of clinical investigations. It begins with defining the term clinical trial and explores the history of clinical trials. It examines the responsibilities of parties involved in clinical trials and the importance of clinical studies in overall drug development. next, it outlines the different types of clinical studies and designs, as well as the selection of study objectives, subjects, endpoints, methods to minimize bias, control group and sample size. then it looks at the regulatory requirements and internationally accepted practices for the conduct of clinical trials. Lastly, it concluded with the clinical trial registries and databases. Basics of clinical trials Clinical trial regulations and internationally Clinical study design methods accepted practices For more information, visit DIAglobal.org/eLearning 11

12 Clinical research BIoreSeArCh monitoring ProgrAm (BImo): IntroDuCtIon get an overview and historical perspective of fda s Bioresearch monitoring (BImo) program and the methods and techniques used in conducting and reporting nonclinical laboratory, clinical investigator, Institutional review Board (IrB), sponsor/monitor, and in-vivo bioequivalence inspections. Evolution of FDA s regulatory history Regulations and expectations that are part of BIMO terminology fda s BImo program Purpose of FDA s BIMO program How FDA implements the clinical BIMO program CLInICAL DeVeLoPment ProCeSS: InVeStIgAtIonAL ProDuCt, PLAn, AnD DAtA management this module covers the process of developing a research protocol for human investigation and testing for medications that are not sold or available in the United States. The phrase clinical research is a phrase specific to research involving human participation. this process requires recruitment and enrollment of patient volunteers who will participate in an investigational study for a new product not currently sold. The term investigational study will be used interchangeably with the phrase clinical research trial. Likewise, and for the purpose of this module, the word study will be used interchangeably with trial. this module outlines the steps and obligations that need to be taken by a sponsor of a new drug, or product, before the new drug is available for sale. Discussions will include required steps specific to the investigational drug approval process, and when applicable, device clinical trials specific to premarket approvals (device trials with human subjects). Requirements for financial disclosure How FDA evaluates the clinical Who is responsible for disclosing financial information investigators financial disclosures Flexibility to Learn Anywhere, Anytime - at Your Own Pace 12 elearning Catalog

13 CLInICAL InVeStIgAtor elearning ProgrAm A Program this elearning program provides a unique, realistic opportunity for clinical research professionals to learn the regulations, process, and best practices of conducting safe and effective clinical trials. the program follows the activities of a fictitious clinical investigator named Dr. richard hughes, and his staff as they conduct a clinical trial for a fictitious drug. At various points during the study, you will be required to make a decision about how Dr. hughes or others should proceed, or address the situation at hand. As you work through the decisions around the activities in the clinical trial, the program will explain how each of the realistic scenarios relates to the regulations, guidelines, and practices for conducting clinical trials. Purchase both Modules and Save $100 Program Includes two modules: Clinical Investigator: Module 1 Study Preparation and Initiation Clinical Investigator: Module 2 Conducting the Study CLInICAL InVeStIgAtor: module 1 StuDy PrePArAtIon AnD InItIAtIon In module 1, the focus is more on the activities that occur before a clinical trial begins: study preparation and study initiation. Dr. hughes and his staff go through a fictitious clinical trial. Clinical trial site preparation Ethics and regulations in clinical research Informed consent process CLInICAL InVeStIgAtor: module 2 ConDuCtIng the StuDy In module 2, the focus is more on the activities that occur during the trial. Adverse events and safety monitoring Study closure Managing monitor visits CLInICAL trial AuDItS AnD ConSeQuenCeS of non-compliance Sponsors of clinical trials can put measures in place in an attempt to dissuade researchers from being noncompliant, but those measures are only as effective as the personnel applying them. this module will provide a description of the clinical trial audit process and how audits help to ensure trials are conducted in accordance with regulatory requirements. Actions that can be taken if investigators are not compliant will also be discussed. Clinical trial audits Compliance with clinical trial regulations Clinical trial audit process and noncompliance consequences FDA clinical trial inspections For more information, visit DIAglobal.org/eLearning 13

14 Clinical research ComPuterIzeD SyStemS InSPeCtIonS In the medical DeVICe InDuStry this module has been designed by International Society for Professional engineers (ISPe) and eduneering, Inc. in cooperation with the fda/ora, to assist fda inspectors in recognizing the critical aspects of computerized systems in the medical device industry. the module explains how computerized systems are used in the medical device manufacturing process and provides an approach to inspecting these systems. rather than covering medical device software in detail, the module goes over the inspection of systems that automate aspects of the medical device production process and/or quality systems. How computerized systems are used in the medical device industry How investigators should approach computerized systems Investigator reviews of computerized systems used in the medical device industry ComPuterIzeD SyStemS InSPeCtIonS In the PhArmACeutICAL InDuStry this module has been designed by the International Society for Professional engineers (ISPe) and eduneering, Inc. in cooperation with fda/ora, to assist fda personnel in recognizing the critical aspects of computerized systems in the pharmaceutical industry during pre-approval and routine gmp inspections. the module explains how computerized systems are used in the pharmaceutical manufacturing process and provides an approach to inspecting these computerized systems. After completing this module, you should be able to recognize where computerized systems are used in the pharmaceutical manufacturing process, recognize fda s approach to inspecting computerized systems, and identify the levels of review that may be used and what comprises each level. How computerized systems are used in the pharmaceutical industry How investigator s should approach computerized systems Investigator reviews of computerized systems used in the pharmaceutical industry ethical review BoArDS this module addresses the role, responsibilities, and regulatory requirements of Institutional review Boards (IrBs)/Independent ethics Committees (IeCs) in protecting the rights and welfare of human research subjects. this module reviews the regulations, guidelines, ICh gcp and the eu directive to provide a better understanding of the relationship between the IrB/IeC, sponsor/monitor, and investigator/subjects. upon completing this module, IrB/IeC members, investigators and sponsors/ Cros will understand their obligations in relation to the IrB/IeC and will be able to ensure that policies and procedures developed for compliance will protect and safeguard the research subjects. Development of the ethical review systems Membership/procedures Review and approval Vulnerable subjects Noncompliance Compliance resources 14 elearning Catalog

15 ethics AS the foundation to CLInICAL research Investigational drugs and biologics are tested and characterized during and after administration to humans in clinical trials. therefore the human subjects that volunteer for these trials should be treated appropriately and their safety should be the primary consideration of all involved in the design and conduct of these trials. ethics are at the foundation of clinical trial decision-making. the ethical rules that protect the rights of human subjects should guide the entire industry. this module describes how ethical guidelines protect human subjects and how to design ethically sound trials. the module will also enhance your awareness around emerging trends to be considered in the future. Ethics and human clinical trials Ethical decisions in clinical research Emerging trends in ethics and clinical research european union CLInICAL trials DIreCtIVe get an introduction to the basic structure and contents of the european union Clinical trials Directive. It covers member states responsibilities and status regarding implementation of the directive and how the directive may impact future clinical research. European Union Clinical Trials Directive European Union Clinical Trials Directive European Union Clinical Trials Directive s impact responsibilities on future clinical research good CLInICAL PrACtICeS (gcps) for new ProDuCt InVeStIgAtIonS understand the general requirements of good clinical practices (gcps) and the protection of human subjects, as well as provide information regarding the concepts, individuals, and groups involved with them. What are GCPs What GCPs requirements and international regulations apply Regulatory authority approval for clinical trials Five key GCPs documents PurChASe multiple ul elearning modules At one time AnD SAVe. See PAge 5 for more DetAILS. For more information, visit DIAglobal.org/eLearning 15

16 Clinical research good LABorAtory PrACtICeS (glps) nonclinical laboratory studies are conducted in the early stages of bringing a new pharmaceutical, biotechnology, or medical device to the marketplace. Best practices must be followed to ensure the reliability of the study and the safety and efficacy of the product. This module will introduce you to good laboratory practice regulations (glps) and their application to nonclinical laboratory studies. Lessons include terminology, acceptable practices for nonclinical laboratory studies, and the role that good laboratory practices play in assuring the validity of these studies. What are GLPs GLPs guidance How do GLPs regulate personnel? How do GLPs regulate a protocol? Documentation required by GLPs Why GLP inspections are conducted GxPs get a basic overview of good laboratory practices (glps), good clinical practices (gcps), and good manufacturing practices (gmps), collectively known as gxps, as well as an outline of the process by which drugs, medical devices, and biologics are approved for the marketplace. GLPs, GCPs, and GMPs basics Approval process for pharmaceuticals, GxPs as a whole medical devices, and biologics hipaa the ImPACt on CLInICAL research the health Insurance Portability and Accountability Act of 1996 (hipaa) aims to protect patient confidentiality in the age of health information technology. this module addresses how to best implement the challenges presented by hipaa requirements in the process of new pharmaceutical, biological, and medical device development. you will learn how hipaa could impact the use of information gathered from us clinical trials. HIPAA compliance PHI Enforcements ICs, IRBs, and PBs Waivers Limited data sets Exceptions HIPAA affect on future clinical research 16 elearning Catalog

17 InformeD ConSent this innovative module uses a detailed case study and examples taken from actual consent forms to provide an in-depth analysis of, and the key concepts related to, informed consent. the module also addresses unique situations that do not require consent, alternative methods of communicating consent information to different populations, and changes to informed consent under the health Insurance Portability and Accountability Act (hipaa). Identification of situations that require consent Writing consent forms and related documents Proper methods of gaining consent for studies with different characteristics InVeStIgAtIonAL ProDuCt DeVeLoPment get an overview and summary of the investigational product development process. the module includes information on the different phases of clinical research necessary to file an Investigational new Drug Application (InD) and a new Drug Application (nda). the module discussed the purpose of each phase, key differences between pharmaceutical and medical device development, and factors that contribute to the size and expense of clinical trials. Stages of new product development How the development of medical devices differs from Trial phases drug products FDA approval What trials may be conducted after submission for approval For more information, visit DIAglobal.org/eLearning 17

18 Clinical research ISo 14155: obligations of SPonSorS AnD monitors for medical DeVICe trials ISo is intended to be applied worldwide to clinical investigations of medical devices in order to fulfill the various national, regional, and international regulatory requirements. After completing this module, you will be able to identify the specific requirements of ISo Part I and Part II, as well as be able to recognize the roles and responsibilities of sponsors and monitors in clinical investigations. Ethics CIP Investigator s Brochure Informed Consent Documents Sponsor Monitor LABorAtory SPeCImenS for CLInICAL research get an introduction to regulations and guidelines that oversee the process of laboratory sample collection and shipping human specimens for clinical research use in the united States. After completing this module, you will be able to identify the rules and regulations that apply to laboratory samples, recognize how a sponsor utilizes the services of a central laboratory, how a principal investigator utilizes a local laboratory, and identify the sponsor and investigator site responsibilities for collection of specimen, as well as specimen packaging for shipping. In addition, you will be provided with compliance resources to ensure that sponsors and investigator sites maintain compliance with mandatory regulations. Clinical laboratories Clinical Laboratory Improvement Amendments (CLIA) certification Sponsor role medical DeVICe SAfety reporting Site responsibility and documentation Medical waste disposal Packaging and transport of specimens get an introduction to the regulatory requirements in the medical device clinical trial and postmarketing environments, as well as explore device safety monitoring and reporting efforts in europe. Definition Safety Adverse events Premarket Marketed devices Reports 18 elearning Catalog

19 overview of the CLInICAL research ProCeSS A pharmaceutical, biological, or medical product is generally not introduced into the marketplace unless it has been approved by a country s regulatory agency. this basic module is designed to give you an understanding of the approval process and the importance of developing products that meet regulatory requirements for global registrations. The safety and efficacy of products are approved via clinical trials in humans, by investigators who have demonstrated that the research was conducted under the auspices of good clinical practices (gcps). the principles and applications of gcps are essential in product development, and they are based on regulations, directives, and guidelines meeting global regulatory demands in the conduct of clinical research. All personnel involved in new product development from bench scientists who discover the compounds or devices to researchers to marketing and sales personnel should be aware of what is necessary to bring a new pharmaceutical or medical product to market. GCP Phases of clinical research that follow GCP Timelines and costs Final stages in the clinical research process Regulations, directives, and guidelines that Technical documents required to gain approval govern new product development to market new drugs, biologics, and devices PArt 11: electronic records; electronic SIgnAtureS the principle purpose of 21 Cfr Part 11 is to ensure that when electronic records and signatures are used, they meet the minimum requirements of trustworthiness, reliability, and compatibility with fda s mission of public health and safety. this interactive module is designed to introduce you to the regulatory requirements for electronic records and electronic signatures, as well as fda expectations for compliance. you will also learn specific Part 11 requirements that govern the use of electronic records and signatures as well as fda enforcement of Part 11. Part 11 Basic requirements for electronic signatures apply Basic requirements for electronic records Controls for electronic signatures Security requirements for electronic records FDA enforcement of Part 11 For more information, visit DIAglobal.org/eLearning 19

20 Clinical research PArt 11: electronic records AnD SIgnAtureS APPLICAtIon the module provides industry guidance on implementing Part 11 of the Code of federal regulations (Cfr), which deal with electronic records and signatures, and how the us food and Drug Administration (fda) enforces them. Identify steps to prepare for an inspection Security Electronic signatures System documentation Audit trails ProteCtIon of human SuBJeCtS In CLInICAL trials this module provides you with a working knowledge of informed consent regulations, institutional review board/independent ethics committees responsibilities, and the obligations of the individuals responsible for protecting patient rights and welfare. Protecting subjects Consent forms Consent process Consent exceptions IRB/IEC Responsibilities Procedures and records SeLeCtIng AnD managing CLInICAL ContrACt research organizations (Cros) this module provides information on the processes commonly used to select and manage a clinical contract research organization (Cro) and other supportive contract service providers for the clinical stages of the investigation product development process and the requirements for obtaining an appropriately completed study coordinated, at least in part, by a Cro. Outsourcing Pre-selection criteria Sponsor s responsibilities when using a Cro in clinical research Selection techniques Managing CROs Sponsors communicating with CROs 20 elearning Catalog

21 good manufacturing Practices AWAreneSS of fda InSPeCtIonS for PhArmACeutICAL manufacturers In this module, you will be provided with a general awareness of fda inspections of pharmaceutical testing and manufacturing facilities, including purpose, types, and area/operations typically inspected. you will also explore how firms should handle fda inspections and interact effectively with fda investigators. After completing this module, you will be able to have a general awareness of fda inspections of pharmaceutical testing and manufacturing facilities including purpose, types, and areas/operations typically inspected. you will also be able to identify how firms should handle fda inspections and interact effectively with fda investigators. Scope of FDA inspections Procedures for companies to be prepared Guidance on how to interact with FDA What you can expect at the conclusion of an inspection BIoteChnoLogy: An overview of ComPLIAnCe ConSIDerAtIonS get an overview of the fundamental compliance issues impacting the biotechnology industry. It examines compliance requirements specific to the biotechnology processes such as: cell culture and fermentation; culture media and growth; antibody production; extraction, isolation, and purification; cleaning procedures; and laboratory controls and testing. After completing this module, you will recognize what a biotechnology-derived product is, as well as be able to identify why and how fda regulates them. you will also be able to identify the key manufacturing process for these products, as well as recognize the challenges involved with working with these products. finally, you will be able to identify various controls for biotechnology-derived products. Botanical drug products (BDP) Cell culture Antibody production Testing ChAnge ControL Early intervention programs (EIP) Processing and packaging Controls this program reviews the concept of change control by placing you in the role of the change control manager. throughout the program, you will learn to state the key elements of a change control program, identify key indicators of change, and follow change control regulations. It will also show you how to identify the groups involved in change control and ways to describe the impact of change on product, process, and people. Regulatory requirements for change control Steps in the basic model of change control Indicators of an improper change Elements of change control Processing and packaging FDA notification For more information, visit DIAglobal.org/eLearning 21

22 good manufacturing Practices gmp PrInCIPLeS of SoPs this module reviews the principles of SoPs for an fda regulated environment and provides employees with a working knowledge of what SoPs are, their purpose, how they are structured, information provided, change control, and how SoPs are used in the workplace. After completing this module, you will be able to identify what SoPs are, their purpose, and how they are structured. you will be able to recognize how to handle changes to SoPs, as well as how SoPs are used in the workplace. What information is contained in an SOP Change control Implementation of SOPs in the workplace gmp updates enforcement ChAngeS At the new fda you will learn about the challenges facing fda and the industry with outsourcing manufacturing, as well as what companies can do to prepare for the coming changes. Current environment Enforcement model Expectations Supply chain gmps for API BuLK manufacturers Supplier monitoring Risk prevention Future planning the food, Drug, and Cosmetic Act requires Active Pharmaceutical Ingredients (APIs) to be manufactured in accordance with cgmps. there are, however, no specific regulations in 21 Cfr for APIs like there are for drug products. the fda is proposing regulations, however, they are not yet final. this module is about the basic concepts of good manufacturing Practices (gmps) and how they can be applied to the manufacture of APIs. cgmp requirements for API manufacturing personnel GMP requirements for building and facilities cgmp requirements for manufacturing equipment Requirements for materials and packaging components Process controls for APIs Laboratory controls for APIs Record-keeping requirements 22 elearning Catalog

23 GxPs get a basic overview of good Laboratory Practices (glps), good Clinical Practices (gcps), and good manufacturing Practices (gmps), collectively known as gxps, as well as an outline of the process by which drugs, medical devices, and biologics are approved for the marketplace. GLPs, GCPs, and GMPs basics Approval process for pharmaceuticals, medical GxPs as a whole devices, and biologics IntroDuCtIon to gmps examine the history of gmps, and explore the importance of training, as well as quality control and personal responsibilities. In addition, you will discover the importance of documentation and tracking practices. Documentation Responsibilities Contamination control Inspections For more information, visit DIAglobal.org/eLearning 23

24 good manufacturing Practices Key ConCePtS of ProCeSS VALIDAtIon through the use of interactive examples focused on producing a fictitious product, this program will outline the actual activities that take place before, during, and following the validation of a process. throughout the program, you will learn terminology and concepts related to the validation of manufacturing processes, the regulatory requirements for process validation, and validation approaches. A validation life cycle model is used to explain how major elements of validation and how they relate to one another. After completing this module, you will be familiar with applicable regulatory requirements and other important aspects of process validation. Why processes are validated Process validation vs. verification Types of processes that must be validated orientation to gmp ComPLIAnCe Common approaches to validation Validation lifecycle fda regulations can confuse even those who work in the pharmaceutical and medical device industries. this interactive module will examine how regulations are applied and interpreted, as well as provide you with a better understanding of how compliance professionals at both the fda and industry firms interpret and apply important regulations, such as good manufacturing practices (gmps). GMP regulations Interpreting the regulations Enforcing FDA regulations PArt 11: electronic records; electronic SIgnAtureS the principle purpose of 21 Cfr Part 11 is to ensure that when electronic records and signatures are used, they meet the minimum requirements of trustworthiness, reliability, and compatibility with fda s mission of public health and safety. this interactive module is designed to introduce you to the regulatory requirements for electronic records and electronic signatures, as well as fda expectations for compliance. you will also learn specific Part 11 requirements that govern the use of electronic records and signatures as well as fda enforcement of Part 11. Part 11 Basic requirements for electronic signatures apply Basic requirements for electronic records Controls for electronic signatures Security requirements for electronic records FDA enforcement of Part elearning Catalog

25 PrInCIPLeS of good DoCumentAtIon Documentation is an important aspect of good manufacturing Practices (gmps). this module provides you with an overview of the importance of documentation, batch records, procedures, and testing throughout the manufacturing process. Good documentation practices Documenting weights Documents required by the GMPs understanding PoSt-APProVAL ChAngeS Proper documentation within a batch production record Documenting laboratory and inspection records this module covers the definition and purpose of post-approval changes (PAC). It explores the four categories of change components and composition scale of manufacture, site of manufacture, and manufacturing and the requirements for each level of change. you will learn about PAC guidance and how these documents are used to notify the fda of changes to an approved pharmaceutical application. the module also covers the levels of post-approval changes and the recommended chemistry, manufacturing, and control requirements for each level. Defining post-approval changes PAC guidance documents SUPAC guidance Customized Onsite Training Solutions Maximize Your Organization s Training Budget. Bring DIA Training To You. DIA can tailor any training course or curriculum specifically for your team, department, or entire organizaton. DIA is recognized throughout the life sciences community as the definitive source for information about the discovery, development, and life cycle management of pharmaceuticals, biotechnology, and related health care industries Let us bring the perfect customized training experience to you! exclusive benefits of our onsite training program include: Expert training from professionals in the life sciences arena Quality content delivered to your organization s location, saving time and cost Courses tailored to meet your specific training objectives Continuing education credits for more information contact Jessica.McGrory@diahome.org or visit DIAglobal.org/Onsite and submit a consultation request. For more information, visit DIAglobal.org/eLearning 25

26 regulatory Affairs ACCeSS to unapproved DrugS through ComPASSIonAte use A Module this module describes the legal mechanisms and regulated programs for allowing access to unapproved pharmaceuticals for compassionate use in the european union, united States, Canada, and Australia. It examines eu compassionate use programs by reviewing the differences in the member States programs. next, it discusses the compassionate use programs in the us, by focusing on unapproved drugs potentially available for treatment. Lastly, the module takes an in-depth look at the Canada s Special Access Programme and Australia s Special Access Scheme. US compassionate use Australia Special Access Scheme EU compassionate use Accessing unapproved pharmaceuticals for compassionate Canada Special Access Programme use in the eu, united States, Canada, and Australia how to gain APProVAL to market generic medicinal ProDuCtS In the usa A by Intellego Module this module describes fda s expectations when reviewing applications for the licensing of generic pharmaceuticals and medical products. you will receive the background knowledge necessary to draft an effective submission for an Abbreviated new Drug Application (AnDA). the module reviews the hatch Waxman Act, the law that promotes generic drug development. Practical advice in the form of checklists is provided, and timelines are set out. the AnDA process is also compared and contrasted with the new Drug Application (nda) process. the module describes the regulatory role of the fda in the generic drug approval process so you fully understand how to develop and submit a successful AnDA. Overview of Hatch-Waxman Act Generic drug approval criteria Overview of ANDA process how to maintain marketing APProVALS In europe for CentrALLy AuthorISeD ProDuCtS A Module get an in-depth review of the postmarketing activities for medical products authorized via the centralised procedure In europe. Maintaining marketing authorisation validity Enlarging the terms of a marketing authorisation Updating the terms of a marketing through extension applications authorisation through variations, including Fulfilling post-authorisation commitments, such urgent safety restrictions as follow-up measures and specific obligations Submitting annual reassessments Applying for renewals 26 elearning Catalog

27 how to register A new Drug In the usa A Module Learn how to register a drug through the new Drug Application (nda) process under the Center for Drug evaluation and research (CDer). It outlines submission requirements and document preparation steps, and provides you with an in-depth analysis of the nda review process and sponsors opportunity for interaction with the fda. NDA process under the CDER NDA review process and the FDA how to register medicinal ProDuCtS through the CentrALISeD ProCeDure A Module this module provides you with a practical approach on how to register a pharmaceutical or medical product using the centralised procedure. It details the products to which it applies and describes the items and actions that need to be considered in the pre-submission phase. It discusses administrative aspects of a submission and activities undergoing from Day 1 to Day 210 of the procedure. finally, it analyses the steps in the decision-making process and main post-authorisation activities. Identify the legal basis and scope of the Explore the aspects taken in the decisioncentralised procedure making process Identify the main post-authorization activities For more information, visit DIAglobal.org/eLearning 27

28 regulatory Affairs how to register medicinal ProDuCtS through the DeCentrALISeD ProCeDure A Module this module provides you with a practical approach on how to register a pharmaceutical or medical product using the decentralised procedure. the module examines the products the procedure applies to and describes the steps for completing and submitting a marketing authorisation application. the phases and key events of the evaluation process and the possible outcomes of the procedure are discussed. the module concludes by examining the tasks that occur after the decentralised procedure is finalized and the parties responsible for completing them. Steps for completing and submitting a Explore the possible outcomes of the marketing authorisation application decentralised procedure Examine post-authorisation activities how to register medicinal ProDuCtS through the mutual recognition ProCeDure A Module Learn how to register a pharmaceutical using the european union s mutual recognition Procedure (mrp). this module reviews the administrative aspects of a submission and aspects relating to the quality section of the submission. the module details the initial steps of the procedure, the application assessment, and the referral to the coordination group level CmD(h). the decision-making process by the Committee on human medicinal Products (ChmP) related to arbitration and post-arbitration is also reviewed. the module concludes by describing member states prerogatives, post-authorization activities, and transparency rules. Pharmaceutical registration using the European Reviews what occurs during the evaluation union s mrp process, from the initial steps of the mrp CHMP arbitration and post-arbitration decision- to the decision-making process making process 28 elearning Catalog