FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials: 2-day In-person Seminar
Dr. Mukesh Kumar, PhD, RAC, Senior Director, Regulatory Affairs, Amarex Clinical Research
Thursday, August 28, 2014 | Friday, August 29, 2014
Courtyard Marriott Boston - Cambridge, MA
Thursday, Nov 20, 2014 | Friday, Nov 21, 2014
Course Outline and Approximate Times:
|Day 1 (8:30 AM – 4:00 PM)
||Day 2 (8:30 AM – 3:30 PM)
- 8:30 – 9:00 AM: Registration
- 9:00 – 10:30 AM: Lecture 1: Moving a Product out of R&D
- Issues with research grade material used for laboratory and non-clinical testing
- Optimizing manufacturing processes
- Raw material requirements and process development
- Assessing scalability of manufacturing
- Planning the CMC for a potential IND
- 10:30 – 10:45 AM: Break
- 10:45 – 12:30 noon: Lecture 2: CMC Requirements for an IND Study
- Essential elements of the CMC section of an IND
- Characterization of the active ingredient and finished product
- Various kinds of products: drugs, biologics, botanicals, diagnostics, medical devices
- Manufacturing facility, personnel and equipment requirements
- 12:30 – 1:15 PM: Lunch
- 1:15 – 2:45 PM: Lecture 3: Good Manufacturing Practices: Basics for Beginners
- Core principles of GMP
- Regulatory requirements for different products: drugs to medical devices
- Customizing regulatory compliance to a given product
- Role of discussions with the FDA
- 2:45 – 3:00 PM: Break
- 3:00 – 4:00 PM: Lecture 4: Raw Material Management
- Planning for the early stage with an eye towards large scale manufacturing
- Vendor management
- Raw material handling issues for early stage products
- Manufacturing step development
- 8:30 – 10:00 AM: Lecture 5: GMPs for Phase 1 IND products
- The scope of the FDA guidance document
- Acceptable practices and practical tips
- GMP requirements for exploratory clinical studies
- Specific requirements for drugs, biologics and combination products
- 10:00 – 10:15 AM: Break
- 10:15 – 12:00 noon: Lecture 6: GMPs for Combination Products and 505(b)(2) Products
- Specific issues for various kinds of combination products
- Combination products with one or more new components
- CMC issues for 505(b)(2) products
- GMP and QSR: which to follow for a combination products
- 12:00 – 12:45 PM: Lunch
- 12:45 – 2:15 PM: Lecture 7: Process Validation for Early Stage GMP
- Introduction to process validation for early stage manufacturers
- Step by step instructions for process validation
- Process validation reports and other documentation
- Developing SOPs based on validation processes
- 2:15 – 2:30 PM: Break
- 2:30 – 3:30 PM: Lecture 8: Outsourcing Early Stage Manufacturing
- Logistics of using contract manufacturing organizations for early stage products
- Pilot scale manufacturing requirements
- GMP-grade and non-GMP grade manufacturing
- Benefits and challenges with using local and international vendors
Meet Your Instructor:
||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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Philadelphia, PA (Venue to be announced shortly)
August 28-29, 2014
Courtyard Marriott Boston - Cambridge
777 Memorial Drive,
Cambridge, MA 02139, USA
November 20-21, 2014
Special Offer for the attendees of this seminar:
Rooms available at only $179 per night.
Please note: Hotel rooms are limited and based on availability
How to Reach
General Driving Directions:
From Boston Logan International Airport – BOS: 7.3 mile(s) W
From Manchester-Boston Regional Airport – MHT: 55.1 mile(s) SE
- Exit Airport and take MassPike (I-90) West to Exit 20 (Cambridge)
- Continue straight and cross bridge
- Take first right after bridge onto Memorial Drive
- Hotel is 200 yards ahead on the left.
From T F Green Airport – PVD: 62.1 mile(s) NE
- Follow I-293 to I-93S towards Boston
- Take exit 26B (Storrow Drive West) and continue for 3 miles
- Bear right at the Central Square/MassPike exit and turn right at the light
- After crossing the bridge, take first right onto Memorial Drive and Hotel is on the left.
- Take I95N to I93N
- Then, take exit 26 (Storrow Drive West) and follow Storrow Drive
- Take the Central Square/MassPike exit and turn right at light
- After crossing the bridge, take first right onto Memorial Drive and Hotel is on the left.
- South Station: 5 mile(s) SE
- B.U. Central (on the Green Line): 0.8 mile(s) SE
- Central Station (on the Red Line): 0.8 mile(s) NE
- Back Bay Station (BBY): 3 mile(s) SE
- South Station (BOS): 5 mile(s) SE
Disclaimer: Directions to the venue above have been taken from the hotel website. ComplianceOnline is not responsible for any inaccuracies in the same. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue.
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.
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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Philadelphia, PA, Local Attractions
Boston, MA, Local Attractions
Philadelphia Museum of Art
The Philadelphia Museum of Art sits majestically on a rise at the end of the Benjamin Franklin Parkway. The vast collections of this temple of art make it the third-largest art museum in the country, and an absolute must-see on the city's cultural circuit.
Among its impressive holdings in Renaissance, American, Impressionist and Modern art, some standouts include a great Rogier van der Weyden altarpiece, a large Bathers by Cezanne, a room devoted to Philadelphia's own Thomas Eakins, and Marcel Duchamp's notorious mixed-media Bride Stripped Bare by her Bachelors (The Large Glass), exactly as the dada master installed it.
Valley Forge National Historical Park
With more than 3,600 acres of rolling hills and well-worn trails, Valley Forge is now a magnet for runners, bicyclists and picnickers as well as history buffs.
The vast expanse of open space links the Schuylkill River Trail to the Horse Shoe Trail, turning the park into a major hub in a 75-mile system linking Philadelphia to the Appalachian Trail.
The Liberty Bell Center
The Liberty Bell has a new home, and it is as powerful and dramatic as the Bell itself. Throughout the expansive, light-filled Center, larger-than-life historic documents and graphic images explore the facts and the myths surrounding the Bell.
National Constitution Center
The 160,000-square-foot National Constitution Center explores and explains this amazing document through high-tech exhibits, artifacts, and interactive displays. The Kimmel Theater, a 350-seat star-shaped theater, features “Freedom Rising,” a multimedia production combining film, a live actor and video projection on a 360° screen to tell the stirring story of “We the people.”
The Franklin Institute
An innovator in designing hands-on exhibits before “interactive” became a buzzword, The Franklin Institute is as clever as its namesake. Its eminently touchable attractions explore science in disciplines ranging from sports to space.
Highlights include The Sports Challenge, which uses virtual-reality technology to illustrate the physics of sports; The Train Factory's climb-aboard steam engine; Space Command's simulated earth-orbit research station; a fully equipped weather station; and exhibits on electricity.
Boston Public Garden
This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.
Boston Public Library
The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).
Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.
Museum of Fine Arts
Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.
Museum of Science
The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.
This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.