Course Description:
FDA authority over both innovative and generic pharmaceuticals is not only pervasive, but imposes duties on industry that, if not followed, expose drug companies and their officials to severe penalties, up to and including criminal prosecution.
This two day interactive course will review the foundations for FDA’s authority over pharmaceutical companies and will focus on the three central roles of the FDA relative to drug companies. These include: FDA serving as the gatekeeper to the marketplace, primarily through the drug approval process; the agency’s status as the “cop on the beat” that enforces the FDA’s requirements through both administrative actions (e.g., warning letters) and judicial proceedings such as seizures, injunctions and criminal prosecutions; and, finally, the FDA serves as the sentinel of health issues through its role in overseeing industries’ reporting of adverse events through the process referred to generally as pharmacovigilance.
To ensure your firm does not run afoul of the FDA’s requirements, a detailed understanding of those duties is essential. Attendees at this seminar will leave with the tools necessary to help ensure their companies stay in the agency’s good graces, so they can continue to succeed in the marketplace.
Learning Objectives:
Key goals of the conference will include learning:
- The basics of the FDA statutes and regulations governing the entry into the marketplace of prescription and over the counter drugs
- Key differences between the full new drug application (NDA), the 505(b)(2) NDA, and the abbreviated NDA (ANDA) applicable to generic drugs
- The route to the OTC market: Rx to OTC Switches vs. the OTC Monograph System
- The Orphan Drug Act—incentives for treatments for rare diseases
- FDA regulation of drug promotion and advertising
- Understanding the FDA’s enforcement authority, both administrative and judicial
- The basics of drug good manufacturing practices (GMP) and quality requirements
- Pharmacovigilance requirements, including adverse event reporting
- The investigational new drug process and clinical trials
- General controls, such as registration and listing
Who will Benefit:
This seminar will be beneficial to senior drug company management, as well as middle management and operations personnel from the following departments:
Legal, Regulatory, Compliance, Quality, Sales, Marketing, Manufacturing, Operations, R&D, Medical Affairs.
Course Outline:
| Day One (8:30 AM - 4:30 PM) | Day Two (8:30 AM - 4:00 PM) | ||
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Registration Process: 8:30 AM – 9:00 AM Session Start Time: 9:00 AM
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Meet Your Instructor
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Michael A. Swit, Esq. Special Counsel, FDA Law Practice, Duane Morris LLP Michael A. Swit's practice focuses on solving the legal challenges confronted by the pharmaceutical, medical device, and other life sciences industries in tackling the myriad of legal mandates enforced by the U.S. Food & Drug Administration. Mr. Swit has extensive experience counseling life sciences firms on the demands of compliance with FDA's statutory and regulatory requirements to develop and market safe and effective drugs, biologics, medical devices, IVDs and other products. He also has advised regulated firms on a wide range of FDA regulatory matters, including drug and device approvals, food labeling and safety issues, dietary supplement health claims, and regulatory issues in corporate acquisitions. His experience includes FDA development strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts. He has been addressing critical FDA legal and regulatory issues since 1984. Before joining Duane Morris LLP, he served for seven years as vice president at a preeminent scientific and FDA regulatory consulting firm, where he developed and ensured execution of a broad array of regulatory and other services to clients, both directly and through outside counsel. He has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial activities, including, since 1989, co-directing a three-day intensive course on the generic drug approval process and editing a guide to the generic drug approval process, Getting Your Generic Drug Approved. A former member of the Food & Drug Law Journal Editorial Board, he also has been a prominent speaker at numerous conferences sponsored by such organizations as the Food & Drug Law Institute (FDLI), the Regulatory Affairs Professionals Society (RAPS), and the Drug Information Association (DIA). |
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Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $150 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($150) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.
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Testimonials
I thoroughly enjoyed the seminar! The content of the seminar was excellent.
- Associate Director, Pfizer Global Supply
ComplianceOnline is doing well with organizing seminars and webinars.
- Associate Director, Dr Reddy's Laboratories
Seminar was very good, informative and a lovely speaker making a tedious topic interesting. Overall the subjects are well chosen and the program was well organized and coordinated.
- Director - Global IT Governance, Perrigo
The seminar is good. ComplianceOnline is doing well with organizing seminars and webinars.
- Associate Director, Dr Reddy's Laboratories
The event was really well organized and ComplianceOnline staff helped make it a smooth process from initial registration, hotel bookings and seminar materials and stationery. I will be asking my company to send more employees to attend ComplianceOnline seminars.
- Legal Advisor
I've attended quite a few seminars by different training providers but ComplianceOnline was by and far the best - the courses are well designed and up to date with the latest developments and the support staff are always helpful, ready to answer your queries.
- Chief Executive Officer
The instructor was not only active and helpful during the seminar and workshop, but was available to answer resulting queries after the event as well.
- Vice President
I think ComplianceOnline seminars are value for money - the instructors are well prepared and ready to go beyond and above the call of duty to answer even the most complicated of queries regarding subject.
- Internal Auditor
Really good location with good lunch. This seminar was full of valuable topics.
- System Admin, IT
This is my first experience with ComplianceOnline and I would definitely attend other seminars.
- Business System Analyst
It was a very well organized in terms of course, venue and speaker. The content was complete and extremely interesting and I would definitely recommend this seminar to my co-workers. ComplianceOnline has chosen a very good venue.
- Regulatory Advertising Officer, Health Canada
Interaction between the speaker and audience was interesting.
- DVM, Merial
This was tremendously informative and very full of interesting insights. I especially enjoyed going over the warning letters.
- Program Manager, Regulatory Affairs, Genentech, Inc.
Instructor is experienced and was willing to share his experiences.
- Marketing Manager, Minerva Surgical, Inc
Seminar covered more latest up- to- date information.
- Regulatory Affairs Specialist, AccessClosure, Inc
Michael has a good accessible presentation style and was very colloquial. He welcomes questions from attendees and has the answers also. He also promoted good interaction between attendees.
- Sr. Counsel, Siemens Medical Solutions USA, Inc
I had registered for a seminar but unfortunately I was not able to attend. The company was very understanding and extremely helpful. I plan on attending a future event soon.
- Director of Regulatory Affairs, Nickell Physician & Pharmacy Services
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