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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.

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Houston Texans Preseason Home Game v Tampa Bay

cash, visa, mc, amex & discover - no checks TO PICK UP Will Call -- you must present your confirmation number, a picture ID and the credit card used to purchase your tickets. You must wait 48 hours after ordering to pick up your tickets. For NRG Stadium information 832-667-1400. Monday-Friday 10am-5pm Saturday 10am-2pm. Hours subject to change.

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Tokyo International Art Fair - VIP Ticket Fri 5 June 2020

[JPN] 手数料無料 - コレクターが接続して、直接アーティストと係合するための東京国際アートフェアには、国際的なネットワークを確立するために、日本の最初の商業フェアである。才能のある出展者はすべて、ヨーロッパ、英国、米国、オーストラリア、地元のアジアのアーティストの上から来ている。 あなたは、多様かつカラフルなアートフェアを楽しみにすることができます。選択は、写真、イラスト、絵画、オーダーメイドの工芸品も彫刻に基づいています。高品質の作品、異なるメディアや技術を用いて実装されているユニークで魅力的なスタイルのコンセプトを提供しています。すべての芸術作品は、手頃な価格で購入できます。 [ENG] TOKYO International Art Fair is the first commercial fair of Japan to establish an international network for Collectors to connect and engage with the Artists directly - commission free. With talented exhibitors coming from all over Europe, also UK, US, Australia, and local Asian artists.  You can look forward to a varied and colourful art fair. The selection is based on photographs, illustrations, paintings, bespoke crafts and also sculptures. Offering high-quality artworks, unique and fascinating style concepts that are implemented with different media and techniques. All artworks are available for purchase at an affordable price.TOKYO ART FAIR TICKETS:Friday 5th June 2020 : 18.00pm - 21.00pmVIP Tickets ¥ 1500 JPY (£ 10 GBP / € 10 EUR) - Book This Ticket to attend. Including Champagne Reception, Private View and first opportunity to buy art. Saturday 6th June : 11.00am - 18.00pm FREE entry - Prebook here. Live painting, Buy Art Show, Global Art Awards Ceremony (17.30pm) LOCATION:BELLESALLE Roppongi   |   7 Chome−18−18, Minato, Tokyo 106-0032 Japan TOKYO ART FAIRチケット：5日(金)： 18.00pm - 21.00pmブックこのチケットが出席する -  VIPチケットは1500円（ GBPは/€ 10ユーロポンド8 ）¥ 。シャンパンレセプション、プライベートビューとアートを購入する最初の機会を含む。6日(土)：11.00am- 18.00pmFREEエントリ - ここにPrebook 。ライブペインティング、購入するアートショー、グローバルアート授賞式（ 17.00pm ） www.tokyoartfair.com Organised by the Global Art Agency The GAA.

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New York Yankees vs. Tampa Bay Rays

Visa, Mastercard, and American Express. No Cash Will Call is not currently available as a delivery option. The Stadium Box Office will be open on day of game(s) to help with Mobile Ticket troubleshooting. Location: Right Field and Main Box Offices Windows Open: Spring Training: 2 hours before game. Tampa Tarpons: 1 hour before game. (813) 879-2244 Right Field and Main Offices will only open on day of Game. Any advance sales must be made online or by contacting the Steinbrenner Field Ticket Office via phone. Hours to reach a Box Office Representative by phone are Mon-Fri 9:30am-5:30pm This is an accessible venue.

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Bridging The Gap To A Strong Connection - Family Reunion

Hello Family, SAVE THE DATE FOR OUR 2020 FAMILY REUNION. More information coming soon just wanted everyone to save the date and to have time to put in vacation request.  Please RSVP you and the family so that we can get a proper head count. Orlando, FLJuly 16-19.

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