Course Description:
All sponsors of clinical trials in the US for drug and biologics have to first file an Investigational New Drug (IND) application with the FDA containing extensive information in support of the proposed clinical trial. The IND application contains all available preclinical and clinical testing information, and all manufacturing information for the investigational product, along with clinical protocol, informed consent template, investigator’s brochure and other relevant information. For special situation such as orphan products additional considerations might apply regarding all aspects of the IND from protocol design to the background preclinical data and details of manufacturing information. Failure to submit a satisfactory IND could lead to FDA imposing a clinical hold on the clinical trial in turn adding additional expense and delay to a clinical trial.
Attending this workshop is a good step toward making sure that your next IND meets FDA requirements and gets a “Safe to Proceed” letter from the FDA within 30 days from submission. Also discussed will be special situations such as INDs for orphan drugs and botanical drugs. The session topics are arranged in a logical chronology to ease the understanding of complex issues and possible solutions. This workshop contains a collection of practical tips from the trainer’s extensive IND submission experience.
Who will Benefit:
- Sponsors of INDs
- Orphan drug developers
- Supervisors, and lead workers in Regulatory Affairs
- Project management personnel
- Senior management executives (CEO, COO, CFO, etc)
- Manufacturing managers, supervisors & personnel
- Clinical and preclinical laboratory managers
- People investing in FDA-regulated product development projects
Course Outline and Approximate Times:
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Meet Your Instructor:
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Dr. Mukesh Kumar Senior Director, Regulatory Affairs, Amarex Clinical Research Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has written more than 40 new INDs for FDA submission and reviewed more than 100 INDs. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA. |
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- Fill this form with attendee details & payment details
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Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]
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Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)
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 $200 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 ($200) 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.
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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
What past attendees say:
I enjoyed the practical answers and lessons learned as shared by the presenter. Grateful for the sharing of presentation material (soft copy). Thanks to ComplianceOnline for timely response and communication. Variety of choices is extensive good and easy to register.
- Manager, Process Optimization, Prolong Pharmaceuticals, LLC
Excellent instructor and he was easy to follow and I like the thorough and thoughtful answers of my questions.
- Senior Scientist, CCS Associates
Instructor is very knowledgeable and good in explaining regs and guidance. Information provided along with soft copy of slide is a great idea and very helpful.
- Sr. QA Manager, Theravance
Overall a good general overview. The amount of interaction between the participants and presenter was good.
- Asst. Director QA, Clinical Packaging, Abbott Labs
GMP expectations was the most valuable topic for me. Face to face interaction and networking was good.
- Director of Pharmacy, Pfizer New Haven Clinical Research Unit
Speaker’s knowledge was higher than I had hoped.
- Director, BioMed IRB
For me the whole event was very good. I had no knowledge of the topic prior to this seminar. The presentation was excellent and the speaker was very knowledgeable and respectful.
- Quality Assurance Specialist, Therapure Biopharma Inc.
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