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The Veterinary Drug Approval Process and FDA Regulatory Oversight: 2-Day In-Person Seminar
Course Description: The U.S. Food and Drug Administration’s Center for Veterinary Medicine or CVM is responsible for the approval of veterinary drug products intended for both family pets and food-producing animals. FDA regulates not all products intended for animal use. Jurisdiction over animal products including licensed biologics such as vaccines is shared with a number of other federal agencies. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service or APHIS; and products such as flea and tick collars are regulated by the Environmental Protection Agency. This seminar on veterinary medicine regulations will provide attendees with a comprehensive understanding of FDA’s veterinary drug approval process. This two day interactive course will cover: Premarket approval process Various sections of a New Animal Drug Application Strategies for navigating the FDA approval process and for expending product approval The nature of shared jurisdiction over veterinary products in certain cases. Learning Objectives: Upon completing this course on veterinary medicine regulations participants will: Understand how the U.S. Food and Drug Administration regulates veterinary drug product. Understand how FDA’s Center for Veterinary Medicine is organized. Discuss the process by which veterinary drug products are reviewed and approved. Learn how to open an INAD File and request fee waivers. Obtain a working knowledge of various sections included within an NADA. Develop a deep understanding of what is needed to substantiate product characterization, target safety and effectiveness. Analyze FDA’s rules governing chemistry, manufacturing and controls or CMC. Understand the various components of an animal field study to support product approval. Discuss the difference between FDA’s various user fees and fee waivers. Identify the elements of an FDA compliant label. Develop a corporate compliance strategy covering labeling, marketing and advertising. Problem solving methods to mitigate regulatory enforcement risks. Explain how jurisdiction is split between various Federal agencies in a certain cases. Learn how animal feed, veterinary devices, OTC drug products and nutritional supplement are regulated in the U.S. Who will Benefit: This course is designed for people tasked with developing and maintaining an animal health company’s product portfolio; and responsible for overseeing a company’s regulatory strategies. This includes individuals responsible for overseeing regulatory affairs, developing strategies for obtaining veterinary drug product approvals and those tasked with ensuring corporate compliance. Among others, this includes: Senior quality managers Quality professionals Regulatory professionals Compliance professionals Production supervisors Manufacturing engineers Production engineers Design engineers Labelers and Private Labelers Contract Manufacturers Importers and Custom Agents U.S. Agents of Foreign Corporations Process owners Quality engineers Quality auditors Document control specialists Record retention specialists Medical affairs Legal Professionals Financial Advisors and Institutional Investors Consultants, Inspectors and cGMP Experts Speaker: Mark HughesConsultant, Hughes Veterinary Consulting Dr. Mark Hughes, DVM, MS, has over 11 years of experience in veterinary drug product development and over 20 years of experience in laboratory animal medicine, development of in-vitro diagnostic tests, and research in animal reproduction. He has managed or contributed to clinical studies and regulatory submissions on the safety and effectiveness of veterinary drugs (including stem cells) for therapeutic treatments related to dermatology, cardiology, endocrinology, oncology, osteoarthritis, and infectious diseases. Through his consulting business, Hughes Veterinary Consulting, he assists domestic and international biotech and pharmaceutical companies with the process of applying for regulatory approval of drug products for use in companion animals and livestock. For Registration - http://www.complianceonline.com/the-veterinary-drug-approval-process-and-fda-regulatory-oversight-seminar-training-80155SEM-prdsm?channel=eventbrite Note: Use coupon code REFERRAL10 and get 10% off on registration.
read moreNational Private Lender Expo Real Estate & Business Conference
The National Private Lender Expo/Real Estate Conference is where private lenders from across the country assemble and meet face-to-face in the exhibitor hall with major players in the commercial and residential real estate industry. Connect with private lenders actively deploying capital for your next deal. Enjoy interesting speakers from leading private lending and distressed debt investing institutions. Meet real estate owners, developers, managers, operators, distressed debt investors, private investors from across the country seeking commercial bridge loans, residential fix/flip loans and business capital for their next deal. Featured Sponsor: PrivateLenderSearch.com - The private lender search engine for the private lender industry. Visit PrivateLenderExpo.com for exhibitor and speaking opportunities. NOTICE OF FILMING AND PHOTOGRAPHY CROWD NOTICE CONSENT AND RELEASE. CONSENT TO USE OF VOICE, NAME AND LIKENESS EVENT OPERATORS LLC AND/OR ITS AGENTS OR THIRD PARTIES WILL BE PHOTOGRAPHING, RECORDING AND FILMING THIS EVENT. BY ENTERING THE EVENT YOU ACKNOWLEDGE THAT YOU HAVE BEEN FULLY INFORMED OF YOUR CONSENT, WAIVER OF LIABILITY AND RELEASE BEFORE ENTERING THE EVENT BY ENTERING THE PREMISES, YOU IRREVOCABLY CONSENT TO THE USE OF YOUR VOICE, NAME AND LIKENESS IN ALL PHOTOGRAPHS AND AUDIO AND VIDEO RECORDINGS MADE DURING THE EVENT. THESE ELEMENTS WILL BE USED SOLELY BY EVENT OPERATORS LLC FOR PROMOTIONAL PURPOSES, INCLUDING BUT NOT LIMITED TO, FOR EXHIBITION, TELECASTS, STREAMING OR INCLUSION ON WEBSITES AND SOCIAL MEDIA PLATFORMS, AND MAY BE USED WORLDWIDE AND IN PERPETUITY. YOU WILL RECEIVE NO COMPENSATION AND WAIVE ALL RIGHTS YOU MAY HAVE TO ANY CLAIMS FOR COMPENSATION OR ROYALTIES IN CONNECTION WITH ANY USE OF THESE ELEMENTS AND WAIVE ANY RIGHT TO INSPECT OR APPROVE ANY PHOTO, OR AUDIO OR VIDEO RECORDING. YOU RELEASE EVENT OPERATORS LLC, ITS OFFICERS, DIRECTORS, EMPLOYEES, SUCCESSORS, ASSIGNS, LICENSEES, AGENTS AND FROM ANY LIABILITY WHATSOEVER IN ANY NATURE CONNECTED WITH TAKING, RECORDING, DIGITIZING, PUBLICATION, OR USE OF PHOTOGRAPHS, OR AUDIO OR VIDEO RECORDINGS, OR THE DISSEMINATION OF EACH.
read moreAnaheim Ducks vs. Buffalo Sabres
American Express, Discover, MasterCard, and Visa are accepted. Honda Center is a cashless venue. A photo ID matching the name the tickets are placed under is required. VIP, Artist, Promoter, or other special will call requirements and locations are subject to change. Will call windows are located at the Box Office. Will call is generally available beginning 1-1/2 hours prior to the event, and closes after the start of the event (after the first intermission for Anaheim Ducks games). Late pick up will be available at the East Entrance after the box office closes. Box office phones are answered during regular box office hours. Please note, the box office does not sell tickets by phone. Call (714) 704-2500 for general information Monday through Friday 10am to 3pm. The box office will remain open through the beginning of weeknight events. On event Saturdays and event Sundays, the box office will open three (3) hours prior to the event and remain open through the beginning of the event. The box office is located on the east side of the building, near the East Entrance, facing the Santa Ana riverbed. Wheelchair accessible seating is available in most areas of Honda Center including Plaza, Club, and Terrace levels. Availability of locations is dependent upon event seating configuration. For availability and exact locations based on a particular event, please toggle the Accessibility icon in the seat map filters on the Ticketmaster.com event page. The box office will have the same availability as Ticketmaster. Please note, semi-ambulatory or limited mobility seating is also available and requires the guest to navigate some steps. Wheelchair accessible seats have no steps. Hearing Impaired Guests: Assistive listening devices are available, with a picture ID as a deposit, at the Guest Services Desk located at Section 214. Requests for sign language interpreters must be received at least 14 business days prior to the event you are attending. To arrange for courtesy sign language interpreters, please either email accessibilityservices@hondacenter.com or call 714-704-2400. For a full list of ADA policies, please visit https://www.hondacenter.com/arena-info/ada-accessibility/
read morePMP® Certification Training in Jakarta
Get ready for 4 days of fast-paced, hands-on training for the PMP (Project Management Professional) certification in Jakarta. The course is aligned to version 6 of PMI's Project Management Body of Knowledge (PMBoK). Your instructors are project managers who're also active PMP credential holders with significant real-world experience both inside the classroom as well as in live projects. Your peers in the training would include Program Managers, Delivery Managers, Project Managers, Associate Project Managers, and Project Leaders from the industry. This phenomenal learner cohort combined with our top-notch instructors will give you a learning experience like no other. GreyCampus is a Global PMI Registered Education Provider (ID 3871) What's Included... 4 days' classroom training in Jakarta Additional 1-day hands-on exam solving session (live online) A 35 Contact Hours' project management education certificate 3 Simulated PMP exams 1 Year e-learning access to our official PMI approved courseware Instructor helpline - 30-day access to an instructor (email based) for doubt clearing and issue resolution 100% Money Back Guarantee Dates: December 17,18,19,20 2019 Time: 9am - 5pm UTC +7 WIB
read moreHamilton (Touring)
Visa, MasterCard, American Express, Cash, Discover Please pick up tickets 1 hour prior to show. Customers must present photo ID, actual credit card used to purchase tickets and confirmation number. (617) 259-3400 Skip the service fees. Buy tickets at the box office! Monday through Friday 10AM to 5PM (non performance weeks) Open 2 hours prior to matinee on weekends and closes ½ hr after curtain. Open 10am until ½ hr after curtain on weekdays. Accessible seating is sold on Ticketmaster. Sight impaired seating and hearing impaired seating, is handled through the box office only for these events.
read more财福人生的盛宴(二)-自我激励,从心领导
题目:财福人生的盛宴(二)-自我激励,从心领导。简介:快乐型员工工作高效,但是是否有对工作的满足感就足够了呢?U-M的研究者研究认为,自我激励型员工更高效。U-M Ross商学院管理与运营学教授Gretchen Spreitzer提出,"自我激励型员工不仅是有对现状的满足感,更要有对未来的不断开拓与创作。自我激励型员工不仅保持高度的活力,还会避免过度疲劳。"Spreitzer和Porath近期在《哈佛商业评论》中发表了研究结果,自我激励型员工比员工平均表现高出16%,过度疲劳现象减少125%,组织认同率高出32%, 工作满意度也要高出46%。同时,他们会更少发生工作失误,更少看医生,节省了更多医疗费用和误工时间。研究者指出,自我激励包括两个方面:活力和学习能力。Spreitzer提出:员工的活力是指对工作保持热情和动力,并能激励其他员工。公司通过提高员工的成就感来促进自我激励。而学习能力在于在工作中不断学习新的知识和技能。不断学习的员工更坚信自己未来的发展成就课程特色☆深刻去审思忙碌背后和人生的目标的意义来加强心理正能量以应对一直改变的外在因素☆从个人真实成长例案,来学以致用,进而创造价值和影响力☆通过实用的正确态度和心态去自我激励,进而影响团队,和企业共同往幸福前进。对象:公司的领导层和企业老板目标:(i) 让公司领导和老板反思忙碌背后所忽略的重要点滴,往内心做深刻的审查。(ii) 让公司领导和老板,从新调整正确的心态,态度和信念来自我激励,然后以身作则带领公司团队,一同提升,往共同目标前进。日期:只是供参考,真实日期待洽商课程安排:只限企业内部培训安排,没有公开授课时间:一天课程9am-5pm内容:1. 忙碌背后的审思 -忙碌的意义,忙什么?-生命的意义和目的?-人生目标?写下来?-莫忘初心?-迷失方向?-忘了自己?-独处的宁静?-老样子?-同样的经验用20年?2. 正确心态和习惯-正能量-坚持正确和对的-选择善良-给与的力量-爱没有条件-感恩而不埋怨-心量的大小决定成就的大小。-挑战自我,离开舒适区-你得到你所专注的-莫放弃 3. 换个富脑袋-什么是重要和不重要?-有钱和你想的不一样4. 时间的有限和管理-你还有多少时间?-时间分配-几时可以为自己忙?5. 终身学习-读书,旅行,交际6. 莫忘本分7. 企业就是另一个家课程日期和地点安排接洽012-4142695ceyong@financialfreedom.com.my #幸福企业 #激励 #自我激励 #正能量 #正确心态 #企业培训 #企业 #文化培训 #传统文化 #本分 #以德为本 #仁 #财福人生 #杨子佑硕士
read moreDiversity - Connected 2022
Cash, cheque, credit cards and SOLT Theatre Tokens. Tickets left at the box office for collection may be picked up on the day, during the hour before the performance starts. Please take the credit card used to make the booking and the Ticketmaster booking reference number as proof of purchase. Monday - Saturday 10:00-20:00. Madonna-Accessible tickets ONLY available,by registering for the various Fan Club,Citi or Verified Fan presales via www.ticketmaster.co.uk or by calling 0800 988 4440 (we expect tickets to sell quickly out on-line). All other events apart from Madonna,please call 0207 087 7966 or email access@lwtheatres.co.uk
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