{"title":"9-Hour Regulatory Strategy Development","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eEnhance your regulatory knowledge and advance your career with our\ncomprehensive course on developing effective regulatory strategies for\ndrugs, biologics and devices. As the cost of drug and device development\ncontinues to get more expensive, the need for a sound regulatory strategy\nbecomes more obvious. Your regulatory strategy can help you determine\nif a drug, device or biologic is ready to initiate and support a clinical trial\napplication or to obtain marketing approval. Knowing what to research,\nreview, negotiate and what to include in a regulatory strategy differs by\ncompany; however, basic requirements include:\n\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eTarget product profile\/draft package insert\u003c\/li\u003e\n\u003cli\u003ePast precedence review\u003c\/li\u003e\n\u003cli\u003eClinical development plan\u003c\/li\u003e\n\u003cli\u003eCompetitor label analyses\u003c\/li\u003e\n\u003cli\u003eFDA interaction planning\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003eAs a regulatory professional develops their skill set, knowing how to create\nand implement a regulatory strategy is critical to career advancement.\nThis program will walk learners through a case study focusing on a newly\ndeveloped product and the step-by-step process of creating a regulatory\nstrategy. In this session, you will learn:\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eThe definition of regulatory strategy\u003c\/li\u003e\n\u003cli\u003eRegulatory strategy elements, by phase of development and discipline\u003c\/li\u003e\n\u003cli\u003eHow to research and pull together a strategy\u003c\/li\u003e\n\u003cli\u003eHow to plan and modify the regulatory strategy across the developmental phases\u003c\/li\u003e\n\u003cli\u003eWays to adapt and update a strategy as information changes\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003eParticipants will walk away with a strategy toolbox that can be immediately\n    applied on the job.\n\u003c\/p\u003e\u003cp\u003ePrior to the start of the course, participants will receive their login\n    credentials and links to access and download the many class resources\n    and class meeting links. Upon course completion, participants will be\n    provided training certificates. In order to receive accreditation CEUs,\n    participants are required to pass a final exam. Upon\n    completion of the exam, CEU certificates will be provided.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eIdentify regulatory strategy elements\u003c\/li\u003e\n\u003cli\u003eUnderstand questions to be addressed when developing a regulatory strategy, by phase and discipline\u003c\/li\u003e\n\u003cli\u003eLocate and use available tools to aid in developing regulatory strategy\u003c\/li\u003e\n\u003cli\u003eIdentify and summarize data and perform strategic analysis\u003c\/li\u003e\n\u003cli\u003eDetermine the output and format of strategic information after analysis into a “playbook”\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eCourse Outline\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eModule 1: What is regulatory strategy?\u003c\/li\u003e\n\u003cli\u003eModule 2: What makes good strategic qualities?\u003c\/li\u003e\n\u003cli\u003eModule 3: How to perform strategic analysis\u003c\/li\u003e\n\u003cli\u003eModule 4: Landmines (how to plan for them or mitigate as much risk as possible)\u003c\/li\u003e\n\u003cli\u003eModule 5: Updates and monitoring the regulatory landscape\u003c\/li\u003e\n\u003cli\u003eModule 6: Performing strategy at different phases of investigation and how it differs\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cb\u003eAvailable by individual module! Contact Barnett to learn more.\u003c\/b\u003e\n\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eMid-Level Regulatory Professionals who have 3-5 years of regulatory experience and are looking to learn the “next level” of regulatory, beyond submission preparation\u003c\/li\u003e\n\u003cli\u003eDrug Development Team Members that would like to learn more about regulatory strategy\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003eNOTE: This course is for individual registrants only and does not allow for group training.\u003c\/p\u003e\u003cp\u003e\u003cb\u003eWhat participants say about Barnett's 10-Week courses ...\u003c\/b\u003e\n\u003c\/p\u003e\u003cp\u003e“Great course! Instruction is expertly led and engaging. I will recommend Barnett to any colleague and will seek out topics for my own future training and professional development needs.”\u003c\/p\u003e\u003cp\u003e\"The course has been so incredibly helpful thus far...I look forward to Thursday evenings!\"\u003c\/p\u003e\u003cp\u003e“This class exceeded my expectations of an online learning experience. The instructor was knowledgeable, came equipped with great examples to keep the class interesting and is a strong presenter. Thank you!”\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003cbr\u003e\u003c\/p\u003e\u003cp\u003eJoy Frestedt, Ph.D., C.P.I., R.A.C., F.R.A.P.S, F.R.A.C.P\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/www.barnettinternational.com\/instructor-biographies\/\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer\n            biographies\u003c\/a\u003e\n\n \u003c\/span\u003e\n\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003e\u003cspan class=\"purple-link\"\u003e\u003cb\u003e\u003ci\u003eCourse\n Length and Time\u003c\/i\u003e\n \u003c\/b\u003e\n \u003c\/span\u003e\n\u003c\/p\u003e\u003cp\u003e1.5 hours\/week for 6 weeks.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$1,595 by Early Bird Deadline \u003c\/p\u003e\u003cp\u003e$1,795 after Early Bird Deadline\u003c\/p\u003e\u003cp\u003eThis course is for individual registrants only and does not allow for group training.\u003c\/p\u003e\u003cp\u003eAll participants are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 9 hours (0.9 CEUs) of continuing education credit for full participation, including\n    the completion of a final exam and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-24-065-L99-P. Released: 8\/24.\u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold\n this course at your company! For more information, contact Naila Ganatra at +1\n        215.413.2471.\u003c\/span\u003e\n\u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/9-hour-regulatory-strategy-development.oembed","provider":"Barnett International ","version":"1.0","type":"link"}