- Banking & Financial Services
- BANKING & FINANCIAL SERVICES
- Banks and Credit Unions
- Financial Services and Trading
- Insurance
- Accounting and Taxation
- Life Sciences
- Hitech, Aero & Manufacturing
- HITECH, AERO & MANUFACTURING
- Quality & Safety
- Standards and Methodology
- Energy & Utilities
- ENERGY & UTILITIES
- IT Security
- Reliability (NERC / FERC)
- Quality and Safety
- Risk Management
- CPG & Retail
- CPG & RETAIL
- Retail Audit
- Quality & Safety
- Social Compliance
- Healthcare
- Food & Dietary Supplements
- Cross Industry Functions
The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is responsible for the approval of veterinary drug products intended for family pets, food-producing animals, and other animal species. This seminar will cover the process for obtaining federal government approval for marketing new animal drug products that are under the jurisdiction of the FDA, and also briefly covers animal products that are regulated by other federal agencies. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture, and some flea and tick control products are regulated by the Environmental Protection Agency.
This two-day interactive seminar will provide attendees with an understanding of FDA’s veterinary drug approval process. The group size is small, generally between 8 and 20 people, with plenty of opportunities to ask questions and discuss issues or challenges that the attendees have experienced.
Learning Objectives:
Key goals of the seminar will include learning:
- How the U.S. Food and Drug Administration (FDA) regulates animal drug products.
- How FDA’s Center for Veterinary Medicine is organized.
- The process by which veterinary drug products are reviewed and approved.
- How to open an Investigational New Animal Drug (INAD) File.
- The FDA’s various user fees, what fee waivers are available, and how to request a fee waiver.
- The various technical sections included in a New Animal Drug Application (NADA).
- What information is needed to substantiate product characterization, target animal safety and effectiveness.
- An overview of FDA’s rules governing chemistry, manufacturing and controls (CMC).
- The various components of an animal field study to support product approval.
- How animal feed, veterinary devices, OTC drug products and nutritional supplements are regulated in the U.S.
Who will Benefit:
This course is designed primarily for people tasked with developing new animal drugs for an animal health company or a human pharmaceutical company. This includes individuals responsible for overseeing regulatory affairs, developing veterinary drug products, or evaluating new technologies or applications. Among others, this includes:
- Personnel new to the Animal Health Industry
- CRO professionals
- Entrepreneurs looking to add value to their products
- Regulatory professionals
- Compliance professionals
- U.S. Agents of Foreign Corporations
- Legal Professionals
- Financial Advisors and Institutional Investors
- 08.30 AM - 09.00 AM: Registration
- 09.00 AM: Session Start
- Introduction to the Veterinary Drug Approval Process
- Definitions
- INAD/NADA technical sections
- Some differences between human and animal drug approval process
- FDA organization and jurisdiction
- FDA Centers relevant to Animal Health
- Introduction to Federal Regulations (FD&CA, AMDUCA, ADAA, FDAMA)
- FDA Guidance documents and other online resources
- Discovery/Acquisition - Preliminary Patent Protection Concerns
- INAD/NADA Phased Review
- Open an INAD File
- Submit Early Information
- Phased Review of Technical Sections
- Meetings with CVM
- Brief description of cGxP (GMP, GLP, GCP)
- Developing the NADA Technical Sections
- Chemistry, Manufacturing, Controls (CMC)
- Effectiveness
- The 7 Major Phases of Clinical Field Studies
- Target Animal Safety (TAS)
- Human Food Safety
- Environmental Impact
- Labeling
- Freedom of Information (FOI) Summary
- All Other Information (AOI)
- Overview of Generic Animal Drugs (JINAD)
- Submissions - ANADA sections
- CMC
- Bioequivalence (Safety & Efficacy)
- Human Food Safety
- Labeling
- Submissions - ANADA sections
- Minor Use Minor Species (MUMS)
- Designation
- Indexing
- Marketing Exclusivity & Exclusive Marketing Rights
- Animal Drug User Fees and related waivers
- Animal Feed, OTC Drugs, Supplements, Medical Devices
- USDA & EPA
- Non-Approval-Related Considerations
- Extra-Label Drug Use
- Compounding
- Noncompliance and Enforcement
- Pharmacovigilance
- Post-approval submissions for CMC changes
Mark Hughes
Consultant, 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.
Location 1:
Copenhagen, Denmark
(Venue to be announced shortly)
April 20-21, 2020
Location 2:
Kansas City, MO
(Venue to be announced shortly)
May 14-15, 2020
We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.
Benefits of becoming a Sponsor/Exhibitor/Media Partner:
- Logo on website, marketing email, branding materials & the registration booth
- Exhibit Space
- Free event pass
- Speaking opportunity
- Social media campaign
For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656
Media Partner:
PharmiWeb.jobs is Europe’s largest specialist Pharma Job board. Thousands of active job vacancies listed from hundreds of employers across the UK and Europe; PharmiWeb.jobs is the best place to find your next career move. All you need to do is register and upload your CV.”
Pharmaceutical-Tech is essentially a B2B online business, technology media platform and global magazine that have under its wraps the largest global database of Pharmacy buyers and suppliers. We cover in-depth trends that shape industry dynamics and metamorphose global economics. Pharmaceutical tech has created a recognition that spans over a global audience, thereby revolutionizing how businesses transact.
Local Attractions of Copenhagen, Denmark
Tivoli Gardens
Tivoli Gardens is a famous amusement park and pleasure garden in Copenhagen, Denmark. The park opened on 15 August 1843. With 4.733 million visitors in 2015, Tivoli is the second-most popular seasonal theme park in the world, the most-visited theme park in Scandinavia and the fourth most-visited in Europe, only behind Disneyland Paris, Europa-Park Rust and the Efteling. The park is best known for its wooden roller coaster, Rutschebanen, built in 1914. It is one of world's oldest wooden roller coasters that is still operating today. Another roller coaster, Dæmonen (The Demon), features an Immelmann loop, a loop, and a zero-G roll all during the ride time of just one minute and forty six seconds. The world's second tallest carousel, The Star Flyer, opened in Tivoli in 2006.
National Museum of Denmark
The National Museum of Denmark (Nationalmuseet) in Copenhagen is Denmark’s largest museum of cultural history, comprising the histories of Danish and foreign cultures alike. The museum's main building is located a short distance from Strøget at the center of Copenhagen. It contains exhibits from around the world, from Greenland to South America. Additionally, the museum sponsors SILA - The Greenland Research Centre at the National Museum of Denmark to further archaeological and anthropological research in Greenland. The museum covers 14,000 years of Danish history, from the reindeer-hunters of the Ice Age, Vikings, and works of religious art from the Middle Ages. The National Museum keeps Denmark’s largest and most varied collection of objects from the ancient cultures of Greece and Italy, the Near East and Egypt
Amalienborg
Amalienborg is the home of the Danish royal family. It consists of four identical classical palace façades with rococo interiors around an octagonal courtyard. In the centre of the square is a monumental equestrian statue of Amalienborg's founder, King Frederick V. Amalienborg was originally built for four noble families; however, when Christiansborg Palace burned on 26 February 1794, the royal family bought the palaces and moved in. Over the years various kings and their families have resided in the four different palaces.
Strøget
Strøget is a pedestrian, car free shopping area in Copenhagen. This popular tourist attraction in the centre of town is one of the longest pedestrian shopping streets in Europe at 1.1 km. Located at the centre of the old city of Copenhagen, it has long been one of the most high-profile streets in the city. The pedestrianisation of Strøget in 1962 marked the beginning a major change in the approach of Copenhagen to urban life; following the success of the initiative the city moved to place a much greater emphasis on pedestrian and bicycle access to the city at the expense of cars. Many of the city's most famous and expensive stores, such as Illums Bolighus, Magasin du Nord, and the Royal Copenhagen Porcelain Factory are located along the strip, as well as some of the most famous and expensive luxury brand chain stores in the world. It also features a multitude of souvenir shops and fast food outlets.
Local Attractions of Kansas City, MO
Country Club Plaza
With amazing shops, great restaurants and those famed Kansas City fountains, the world famous Country Club Plaza gets the top pick of About Kansas City's attractions and destinations. The Plaza (as locals call it) was the US's first outdoor shopping, dining and entertainment district and is wonderful any time of year.
Nelson - Atkins Museum of Art
The world renowned Nelson-Atkins Museum of Art (4525 Oak) is one of Kansas City's most treasured gems. With amazing exhibits both inside and out--the Nelson-Atkins boasts one of the most impressive collections anywhere. With everything from ancient Egyptian sculptures and Japanese collection with more than 2,000 works of art ranging from the 10th century B.C.E. you could spend days looking at everything.
Worlds of Fun
Worlds of Fun is the premier amusement park destination in the Midwest, offering 235 acres of excitement and fun for every member of the family, including the newly renovated Oceans of Fun. Come to Worlds of Fun to ride on & slide on all day long.
Kansas City Zoo
The Kansas City Zoo and its adjoining IMAX Theater is a great attraction for those young and old alike. The Zoo has gone through a major transformation in the last few years and boasts over 200 acres with over 900 animals.
Union Station/ Science City
The fully restored Union Station is one of Kansas City's favorite attractions with plenty of great things to see and do. With everything from the fully interactive Science City and its famed Rail Exhibit to movies, planetarium shows and world famous exhibits (think Dead Sea Scrolls and Titanic). They've also got some great restaurants like the famed Pierpont's and the Union Cafe if all that attraction going makes you hungry.
Liberty Memorial and the National WW1 Museum
Liberty Memorial and the WWI museum is the United States official WWI Museum and honor those who served in WWI and honor the memory of the sacrifices those who served made. This interactive exhibit shows the consequences WWI had and the impact it had on the US as a country. The museum and memorial serve as the leading educational institute and resource of WWI. Head to the top of the Liberty Memorial for some of the best 360 view of Kansas City.
We need below information to serve you better
