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, March 26, 2015 | Friday, March 27, 2015
San Diego, CA
Thursday, August 20, 2015 | Friday, August 21, 2015
Manufacturing an investigational product for the initial pilot clinical trials could pose a considerable logistical and financial challenge to developers. The first-in-man and pilot clinical trials are usually conducted in very small number of healthy participants with lower doses primarily to establish safety and hence do not need a significant amount of investigational material. The US FDA allows developers to test early stage investigational products under relaxed GMP requirements.
The manufacturing requirements for early stage clinical trials are designed to assure adequate quality of the investigational product being tested without the excessive regulatory burden of full-scale GMP manufacturing. This workshop will present the current regulations, guidance documents and regulatory strategies available for manufacturing an early development stage product for Phase I and first-in-man clinical trials. Also discussed will be logistical issues with managing the supply of an early stage investigational product, and requirements for stability testing, storage and shipping, labeling, and documentations. Issues specific to special products in early stages of development such as combination products and 505(b)(2) drugs will be discussed. Basics of process validation along to standard process development will be presented. Perspectives for different classes of products will be presented using case studies.
Who will Benefit:
- Supervisors, and lead workers in Regulatory Affairs
- Quality Assurance and Quality Control
- Workers who will prepare GMP documents for early phase products as well as those who will review these documents
- Regulatory affairs workers who will need to deal with submissions covering early phase products.
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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Tampa, FL (Venue to be announced shortly)
March 26-27, 2015
San Diego, CA (Venue to be announced shortly)
August 20-21, 2015
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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Tampa, FL, Local Attractions
San Diego, CA, Local Attractions
Museum of Science & Industry (MOSI)
More than 450 activities await you at this non-profit facility dedicated to promoting a better understanding of science and technology. The Saunders Planetarium shows you the stars. Step inside the Gulf Coast Hurricane exhibit for a blast of tropical nightmare. At the IMAX Dome Theatre, the world is bigger than life, filled with odd sights and sounds on a huge screen. Souvenirs ranging from totes and T-shirts to puzzles and posters are available at the Science Store. For refreshment, the MOSI Café offers pizzas, salads and sandwiches. In late February, the BARF (Bay Area Renaissance Festival) takes place here.
Salvador Dali Museum
Housing the largest collection of Salvador Dali works in the world, the museum offers a regularly changing exhibit of the legendary surrealist artist's melting-watch canvases and a wide variety of his sculpture and fiber objects that are, at the very least, intriguing. One memorable creation toasts the cocktail party; it is a vest covered with full glasses of creme de menthe. Daily tours seek to explain this complex man and his equally complex art. In the museum store you can select a memento of your surreal experience. Do check the website or call for timings.
Tampa Museum of Art
Established in 1979, this museum houses more than 4,500 objects in its permanent collection and exhibits the largest collection of Greek and Roman antiquities in the Southeast. The Center Gallery displays themed exhibitions from the permanent collection. For a look at 19th and 20th century sculpture set against the backdrop of the Hillsborough River, visit the Terrace Gallery. Stroll through the Outdoor Courtyard featuring contemporary sculptures, fountains and bronze work. For gifts, books, children's items or home accessories, stop by the museum store.
Craftsman House is a gallery that showcases contemporary art works. The lush green lawns and beautiful garden welcome visitors in to this creative space. Owned and managed by Stephanie Schorr, it is a gallery-cum-working studio. Here, you will see umpteen art works displayed; jewelry, glass designs and much more work of local and national artists make for its splendid collection. It also has an on-site café serving delicious short eats and variety of beverages including beer and wines. Apart from the art works, Craftsman House also has a pottery studio that features colorful mugs, pots, vases and other wares that will adorn your living room. The innovative designs and art pieces are truly worth a look; so go ahead and visit the Craftsman House soon.
Located right across the street from Busch Gardens Tampa Bay, Adventure Island’s 30 acres of water-drenched fun in the sun features the ultimate combination of high-speed thrills and tropical, tranquil surroundings for guests of all ages. Within a soothing Key West atmosphere await slides, corkscrews, water falls, a wave pool, children’s water playground and other family attractions.
At Busch Gardens, animals roam free and you are the outsider. You can see the park by monorail, cable car or train. Roller coasters, wild animals, entertaining shows, rides, food, shopping, sightseeing, bird shows, exotic flowers, train rides, Serengeti adventures, river rapids...the list goes merrily on. Wear comfy walking shoes and spend the day at this 300-acre park. You can even taste the Anheuser Busch brew that started it all. Busch Gardens is open year-round with varying schedules. Call or see Web site for details.
San Diego Cabrillo National Monument
The first European to set foot in California was the Spanish explorer Juan Rodriguez Cabrillo, who stepped on shore near this spot in in 1542. He's the guy they made this statue to look like - and named the park after. We don't know if Cabrillo climbed all the way up to the top of this promontory or not, but people who make up here nowadays get some of the best views of San Diego, looking across the Bay and back toward downtown.
Sea Creatures at Birch Aquarium
Birch Aquarium is north of San Diego in La Jolla. It's not as big as some of the other aquariums in California or as flashy as the big sea-themed park down the road, but instead just right, filled with interesting exhibits and home to leafy sea dragons like the one above, creatures so improbably they look more like something from a children's book than from the ocean.
Legoland theme park takes its inspiration from Lego toys, those cute little bricks that snap together to build all kinds of fun things. It's one of several Legolands worldwide.
San Diego Zoo Safari Park
The San Diego Zoo's sister park offers a different kind of animal experience. Its name (Safari Park) is the clue and it indeed offers a more safari-like experience. Lots of large animals live in the same big, open areas here - predators kept away from prey, but otherwise much as they would in their natural habitat.
Coronado isn't really an island but a peninsula - a fact that doesn't get in the way of the name most people use for it. Whatever you call it, it's on a slender strip of land between the San Diego Bay and the Pacific Ocean, barely a few blocks wide. What it lacks in size it makes up for in fun, with a beach that's been named among the best in the country, a classic hotel and a compact, lively little downtown. Coronado's laid-back temperament makes a nice break from the busier parts of San Diego across the water.
Originally built for temporary use during the 1915-16 Panama-California Exposition in San Diego, Balboa Park boasts buildings beautiful enough to be considered attractions in themselves, especially if you're a photographer. They're surrounded by trees, lawns and fountains, but that's only the beginning.
In Spanish, La Jolla means "the jewel," an apt name for a pretty, Mediterranean-style seaside town - sitting on cliffs flanking the ocean.
La Jolla visitors like to shop and eat in the nice restaurants, some of them with lovely ocean views. There's a lot for the active visitor, too, including ocean kayaking, tide pool-hopping, surfing at Windansea Beach, biking or running along the waterfront.