| |
| The New Rules:
Gauging the Impact on the
Way We Do Business |
| |
|

The GMPs have been finalized and you have many questions on how they’ll affect the way you do business. Leading industry experts will provide guidance on how to be successful in this newly regulated environment. Join colleagues and meet new ones for this interactive and comprehensive program as we examine together the impact these regulations have on our industry. The Nutrition & Health Forum '08 is a must attend event. No other event this year will bring together this group of expert perspectives! |
Program topics include:
- FDA: Highlights of the New Rule and an Update on Global Supply Issues
- The FTC’s Role in Regulating Dietary Supplement Advertising. A handbook will be distributed to all program participants.
- Market Advantages from the USP, Shaklee and Pharmavite- Regulatory, QA & R&D Manufacturers Roundtable
- Applying the New Rules to Comply: A Manufacturers and Suppliers Roundtable
- Adverse Event Reporting Requirements
- What’s Next from Capitol Hill
- Trends in Manufacturing Methods
- And more!
If you are a dietary supplement professional in the following areas, this is a must attend event, so register today!
- Procurement
- Sales & Marketing
- Management
- Operations
|
|
- Quality
- Regulatory
- R&D
- Formulators
|
Online registration is now closed. Onsite registration will be accepted starting at 2pm on May 6th at the Rancho Las Palmas Resort. Onsite registration will require credit card payment. If you have any questions, please contact the DCAT offices at 800-640-DCAT.
Program Fees
Early Bird Rate (from February 15th-March 31st 5pm EST)*
DCAT Member Company: Single ($395) Couple ($557)**
Non-Member Company: Single ($548) Couple ($710)**
Regular Registration Fee (after March 31st 5:01pm EST)*
DCAT Member Company: Single ($439) Couple ($619)**
Non-Member Company: Single ($609) Couple ($789)**
* Fees include programs and scheduled meals and receptions. Golf and the Wine Tasting, Art Gallery & Shopping Excursion have separate fees.
**Please note that this rate is designated for an attendee who is bringing a spouse/partner or non-business guest. Spouses are invited to attend all programs, scheduled meals and receptions. Two attendees from the same company may not register as a couple.
DCAT Golf Outing at the Rancho Las Palmas Country Club
$150 per person
Wine Tasting, Art Gallery & Shopping Excursion
$50 per person
For any questions about registration, please contact the DCAT office at (800) 640-3228.
Suggested Dress
The suggested dress is business casual.
Sponsorship Opportunities
A variety of sponsorship opportunities are available for the DCAT Nutrition & Health Forum. Inquiries about available sponsorship opportunities can be directed to Kim Butler, MeriCal, (760) 727-0992.
Program Schedule
| Tues., May 6th |
|
|
| 2:00-5:00 pm |
|
Registration |
| 5:30-6:30 pm |
|
Welcome Reception |
| |
|
Dinner on your own |
| |
|
|
| Wed., May 7th |
|
|
| 6:45 – 7:45 am |
|
Breakfast |
| 7:45 – 11:45 am |
|
Education Session I |
| 11:45 am |
|
Lunch on your own or
Golf Outing or
Excursion |
| |
|
Dinner on your own |
| 9:00 – 10:30pm |
|
Nite Caps/Dessert Reception |
| |
|
|
| Thurs., May 8th |
|
|
| 6:30 am |
|
5K Fun Run/Walk |
| 8:00 – 9:00 am |
|
Breakfast |
| 9:00 – 12:15 pm |
|
Education Session II |
| 12:15 |
|
Lunch |
| 2:00 pm |
|
Croquet Tournament |
| 2:00 pm |
|
Tennis Tournament |
| 6:00 – 7:00 pm |
|
Reception |
| 7:00 – 9:00 pm |
|
Closing Dinner with Comedy Club |
Industry Topics:
Education Sessions Wednesday, May 7th, 7:45am-11:45am
Highlights of the New Dietary Supplement GMPs
Sara J. Dent-Acosta, Consumer Safety Officer, Food and Dietary Supplements Division, San Diego Office, FDA
Highlights of the GMPs will be described with emphasis on how these rules are new and unique to manufacturers, packagers, distributors and holders of dietary supplement products. Learn how these rules are similar yet different from drug and conventional food regulations. This discussion will outline who is covered, compliance dates, the role of quality personnel, handling of raw materials, in-process controls and finish product testing requirements.
Legal Perspectives of the New Dietary Supplement GMPs
Paul Hyman, Partner, Hyman, Phelps and McNamara
Now that the GMPs are in place, manufacturing requirements for this newly regulated industry will move FDA enforcement to higher level of priority. Various aspects of interstate commerce enforcement including adulteration, misbranding and shipping will be reviewed. Discussion will include the most important implications of the GMPs and best approaches to compliance.
What’s the Market Advantage? A Regulatory (Safety!), Quality and R&D Manufacturers Roundtable
How can your company gain market advantage and comply with the new rules? Consider the expert opinions from the USP, Shaklee and Pharmavite to help you adapt your company’s strategies.
With over 20 years of regulatory and safety experience James C. Griffiths, Ph.D., Vice President of Food and Dietary Supplement Standards at the US Pharmacopeia, will identify the overall pros and cons GMPs contribute to consumer safety and how your company can embrace the new paradigm for quality and safety with consistent accurately identified ingredients.
Dir. of Quality Assurance, Contract Manufacturing, Shaklee Corporation, Margaret Pazirandeh is responsible for internal quality assurance and cGMP activities as well as those required of their contract manufacturers. She will provide insight on the increased responsibilities of the quality control unit, and additional requirements for raw material and finished product testing. Gain perspective on small vs. large companies as they relate to the timing of compliance to the regulations.
Director Research & Development, Pharmavite LLC, Jones Chan, has more than 25 years of product development experience in dietary supplements, nutraceuticals and conventional food products. Hear perspectives from this market leader on how to assess the necessary responses within R&D in terms of resources and processes without significantly affecting effectiveness and efficiency.
Applying the New Rules to Comply: A Manufacturers and Suppliers Roundtable
Adhering to these new rules may be a challenge for many nutritional supplement companies. To help you prepare your company’s initiatives, this manufacturer and supplier will share their compliance ideas and expectations.
While the new GMP regulations do not require raw material manufacturers and intermediate form processors to meet all of the new standards, it is crucial that compliance with the new GMPs is implemented throughout the value chain serving the nutritional market. Minas R. Apelian, VP/GM, Health & Nutr., Huber Engineered Materials Nutrition will identify the many challenges this raw material manufacturer encounters from culture building, systems development, testing requirements, resource demands, to increased costs in doing business.
Will the new GMPs change the way manufacturers evaluate their suppliers? To be considered a value-added supplier is it price driven or are there more complex factors such as customer support, extensive quality controls in all facets of the supply chain, or concept and technical expertise that significantly contributes to the commercial success of a dietary supplement? Barry Titlow, CEO, Compound Solutions, Inc. will assess these issues and best practices in order to comply with the new rules.
New Adverse Event Reporting-How it Affects Your Business
Ivan J. Wasserman, Partner, Manatt, Phelps & Phillips, LLP
On December 22, 2007, a new law went into effect that requires, for the first time, companies to tell the FDA about reports of serious adverse events associated with the use of dietary supplements. Mr. Wasserman will help you identify if your company is responsible for reporting, provide details on what must be reported and when and how to submit the reports. Determine if your product labels comply with the new law, receive practical tips on how to obtain useful information about adverse events and learn what the FDA may be looking for in an inspection.
Education Sessions Thursday, May 8th 9:00am-12:15pm
FDA, FTC and Supplier Roundtable: Global Supply Challenges
An FDA Update
Alonza E. Cruse, District Director, Los Angles Office, FDA
FDA scientists and laboratories have been working with the nutritional supplement industry and the FTC to uncover and identify fraudulent and adulterated materials being imported into the United States. In this session, the FDA will provide an update on the work being done to ensure the industry has access to quality products.
FTC Advertising Regulations for Dietary Supplements
Ann Stahl, Investigator, Federal Trade Commission
What is the FTC's role in regulating the advertising of dietary supplements? Gain a better understanding of the agency's legal authority and the remedies that exist including court orders, fines and consumer refunds. Recent FTC case studies will also be examined. An FTC handbook covering the requirements for scientific substantiation of advertising claims about dietary supplements will be discussed and distributed to participants.
Sourcing Materials from China
David Zhang, Founder & CEO of Shanghai Freemen LifeScience & Shanghai Freemen Americas
Identify the best materials to source from China to minimize your risk. Discussion will include perspectives on quality assurance practices of Chinese manufacturers and best practices for managing risk when importing from China.
Global Challenges and Opportunities Confronting the Dietary Supplement
Industry: A Capitol Hill Update
John P. Venardos, Vice President, Worldwide Regulatory & Government Affairs, Herbalife International of America, Inc.
A confluence of events finds the dietary supplement industry facing global challenges and opportunities. During his presentation, John Venardos will analyze: (1) the return to majority status by Congressional Democrats for the first time since passage of DSHEA in 1994 and its impact on the supplement industry; (2) active interest by some Congressional leaders in holding hearings and changing DSHEA; (3) impact of FDA’s promulgation of dietary supplement Good Manufacturing Practice regulations to ensure product quality; (4) how the new law mandating the reporting of serious adverse events for dietary supplements and OTC drugs will shape our industry; (5) stepped up enforcement by FDA and FTC; plus (6) the continued proliferation of inappropriate claims by regulatory outliers.
With a Dose of Creativity, Differentiate Your Product
Matthew Knopp, Editor, Tablets & Capsules
The FDA’s final rule is leveling the playing field and reducing the points of difference among makers and marketers of dietary supplements. The result is an increased need for enhancing product differentiation and value. One response to this trend is the application of new formulation and manufacturing methods. Hear the survey results on how companies are changing their manufacturing methods to differentiate their products, and the variations of complexity and cost!
Special Activities Wednesday, May 7th
Golf at the Rancho Las Palmas Country Club
Home to a Ted Robinson designed 27-hole golf course, with fairways that meander over gently rolling terrain and around six lakes at the base of snow capped Mount San Jacinto. Enjoy in the layout of this course, renowned for its secluded sand traps, rolling terrain, palm-lined fairways and magnificent mountain views.
The outing will be in a “scramble” format. If you prefer to play individually, there are a limited number of spots available during the outing. All golf play will begin at 12:30 pm, however please be outside the golf clubhouse by 12:00pm. The cost to play is $150 and includes a boxed lunch. You may also sign-up for golf during the event registration on Tuesday.
Course dress code: No t-shirts, tank tops, athletic shorts, cut-off’s or blue jeans of any type; shorts must be mid-length. Men must wear collared shirts.
Important Note: Golf will begin at 12:30pm. Please be outside the golf clubhouse by 12:00pm for play to begin promptly. Play is expected to end at 6:00pm. If making dinner reservations, we recommend making them for 7:30pm or later. If planning a customer event, please keep in mind the schedule of those playing golf.
Club Rentals
Need clubs? Rancho Las Palmas pro shop will provide a set of Callaway clubs for the fee of $55 per set. When registering for the program, please reserve and pay for your clubs at that time. Any questions about club rentals should be directed to the DCAT office at (800) 640-3228.
Tee & Green Sponsorships that benefit the DCAT’s Excellence in Science Initiative with the NSTA are available for $300 each. If interested, you may add this fee when you register for the program or contact sponsorship chair Kim Butler, MeriCal, (760) 727-0992 or Brian Salerno, Nutralliance, (714) 694-1400 for more information. Thank you in advance for your support.
Wine Tasting, Art Gallery & Shopping Excursion
See the latest works by renowned Palm Springs artists and enjoy a sampling of fine wines at the Palm Springs Wine and Art Gallery. Guests can choose between five samples of either white or red wines. You will learn about each wine as you enjoy the artwork on display in the gallery. After the tasting, guests can select their favorite wine and receive a full serving. Located just steps away from the boutiques of downtown Palm Springs, guests will also have plenty of time to take a stroll in the downtown area.
Transportation to the gallery is provided. The cost of the excursion is $50.00 and includes the wine tasting, gallery visit, light appetizers and transportation. Attendees should have lunch on their own prior to the excursion. The tour bus will leave the resort at 1:30 pm and will return at approximately 5:30pm. You may sign-up for the excursion when registering for the program. Please note that space is limited and is allotted on a first-come, first-served basis. You may also sign-up for this excursion during the event registration on Tuesday.
DCAT Nite Caps & Dessert Reception – A TRADITION!
End your day by joining your fellow program participants and guests for cocktails, dessert and conversation.
Planning a customer event? Please keep in mind the above activity schedules.
Special Activities Thursday, May 8th
Croquet Tournament
Join us for this Nutrition & Health Forum classic! Take in the views of Mount San Jacinto while enjoying a game of croquet with colleagues. Players at any level are welcome to participate.
Tennis
Sign-up to play tennis with your fellow program participants and guests for a round-robin tournament. Open to attendees of all skill levels, this social tournament is great exercise and great fun!
Thursday Night Dinner and Comedy Club!
The Nutrition & Health Forum will end with a closing dinner and a lot of laughs. At this time, all of the awards for each sporting event will be presented. Immediately following dinner, guests will get to experience a first-rate comedy club right at the resort.
Well-known from their performances at top clubs such as the Comedy Store, The HA HA Club and the Improv, these acts will definitely be crowd pleasers. Get ready to Laugh the Night Away with Vicki Barbolak, Mike Pace and Peter Pavone.
Vicki Barbolak, the 2007 Winner of Nickelodeon's "Funniest Mom in America", has been called a modern day Phyllis Diller. Vicki was singled out by E! Television as "...the next breakout star to come out of the world famous Comedy Store."
With over 20 years in the business, Mike Pace has performed throughout the country. He recently debuted at HBO’s U.S. Comedy Arts Festival in Aspen, Colorado. This festival is famous as the place TV execs go to find the Next Big Thing!
Peter Pavone is known for his “boomer” humor. Poking fun at himself and his fellow baby boomers, Peter has headlined at Southern California's major Comedy hot spots.
You are sure to enjoy this evening with your colleagues and friends!
Resort Information
Rancho Las Palmas Resort & Spa
41-000 Bob Hope Drive
Rancho Mirage, CA 92270
Ph: 760-568-2727
www.rancholaspalmas.com
Call the Rancho Las Palmas directly at 866-423-1195 for a room reservation and ask for the special DCAT rate of $184. There is an additional $10 per room, per night Resort Charge. Reservations must be made by April 14th to guarantee this rate.
After completing an incredible $35 million makeover, the new Rancho Las Palmas is classic Rancho Mirage re-imagined for the 21st century traveler. Its bustling, central outdoor plaza connects guests to a world of activity: fine and casual dining, a 20,000-square-foot spa and renowned Yamaguchi Salon, 27 holes of classic desert golf, a 25-court tennis center and four pools. The style of this carefree Palm Springs California hotel is easy and sophisticated and its location enviable – at the foot of majestic Mount Jacinto and directly across the street from The River, a dynamic entertainment, dining and retail area.
Accommodations
- Each of the resort’s 444 guest rooms was completely renovated in October 2007.
- Guest rooms feature plush bedding, a 42-inch plasma screen television and french doors that open onto private patios.
- High-speed internet access is available in each guest room.
Recreation
- A 27-Hole Golf Course designed by Ted Robinson at Rancho Las Palmas Country Club
- The Peter Burwash International tennis center boasts 25 Courts; 22 hard courts and 3 clay courts. Eight hard courts are lit for night play
- A Fitness Center, featuring Cybex equipment, free weights, Elliptical Walkers, Startrac steppers, treadmills, and bicycles
- Other Onsite Activities include fitness trails for hiking and jogging, whirlpool, and spa pool
- The Yamaguchi Salon brings the ancient principles of balance and harmony to your hair, make-up and personal style by analyzing your personality and lifestyle
- Spa Las Palmas offers a complete menu of spa services in a remarkable and relaxing environment
Resort Dining
Program attendees will find a wealth of culinary adventures at Rancho Las Palmas Resort & Spa in Rancho Mirage.
bluEmber
The resort’s new signature restaurant is lighting up the Rancho Mirage dining scene. Designed by the renowned Puccinni Group, bluEmber showcases the region's rich harvest in a setting that exudes the sun-drenched charm of the desert and the relaxed elegance of Southern California. Gather at a handsome carved wood table inside, or by a cracking fire pit on the plaza, for a highly memorable dining experience.
R Bar
Sleek and stylish, this new Rancho Mirage “hot spot” exudes a classic Rat Pack vibe. Settle in with a signature martini or classic cocktail along with a treat from our creative bar menu.
Palms Café
Start your day off right with freshly brewed Starbucks gourmet coffee accompanied by a choice of house-made breakfast breads and pastries. For lunch and dinner, Palms Café is the place to go for an inviting array of fresh salads, signature sandwiches and brick-oven pizzas.
Things to Do and See in Palm Springs
The River - The River at Rancho Mirage is more than simply a shopping and entertainment center. It is a destination. Located directly across from the resort, it provides a park-like waterfront with an entertainment amphitheater, live music, fountains and cascading waterfalls. The River is home to several specialty shops and restaurants.
Palm Springs Aerial Tramway – A thrilling cable car ride shuttles visitors from the desert floor to the heights of Mt. San Jacinto, at times providing a 40-degree temperature drop in just a few minutes. Visit www.pstramway.com for more information.
Dining – Visit www.palm-springs.org for information on all the delicious dining in the Palm Springs area.
About Our Speakers
Minas Apelian, Ph.D., is the Vice President/General Manager of Huber’s Health and Nutrition business unit. Dr. Apelian has been with J.M. Huber for nearly 10 years in a range of roles including Research and Development, Engineering, Business Development, and Innovation. He brings a unique balance of scientific and business acumen to his role. J.M. Huber Corporation is an over 100 year old privately-held company serving customers in a range of businesses including Engineered Materials, Wood Products, Natural Resources, and Financial Services. The Health and Nutrition SBU is part of the Engineered Materials sector and provides a range of calcium products, excipients, specialty granulations, and blending/packaging services to nutrition, pharmaceutical, and food customers.
Jones Chan has twenty five plus years of product development experience in dietary supplements, nutraceuticals and conventional food products. Currently, Jones Chan is the Director of Research & Development at Pharmavite LLC, a manufacturer of dietary supplements and functional foods. Prior to joining Pharmavite, he was the Director of Research & Development at PowerBar where he worked extensively on sport drinks and protein energy bars.
He was also the Vice President of Business Development at Kagome USA, the US operation of Kagome Japan, a leading global manufacturer of tomato products. He worked extensively in the food service sector, managing the development of innovative concepts for national chain accounts. He was a spoke person for the La Choy brand when he was part of the R&D team at ConAgra/Hunt-Wesson. Early in his career, he worked for Shaklee as a process engineer where he commercialized solid dosages, protein drinks and bars.
Alonza E. Cruse is the Director of the FDA’s Los Angeles District Office where his responsibilities includes providing executive leadership to one of the largest District Offices within FDA’s-Office of Regulatory Affairs. Mr. Cruse implements, manages and evaluates FDA's regulatory operations within the District which is comprised of the state of Arizona and southern California including the ports of Los Angeles, Long Beach and an Int’l Mail Facility; and provides the executive leadership and technical direction to a multidisciplinary staff in the execution of investigations, enforcement and compliance programs and in the District's day-to-day management.
Mr. Cruse assumed his current position in October 2000. Prior to assuming his current position, Mr. Cruse was the Director, Import Operations in FDA’s-New York District Office. He serves on numerous committees within FDA including the Medical Device Field committee, the Import Programs committee and the Human Resources committee. He is the past Chair to the Los Angeles Federal Executive Board and past President to the Western Association of Food & Drug Officials (WAFDO). Mr. Cruse holds a B.S. Degree in Medical Technology from York College and is a graduate of USDA's Graduate School - Executive Leadership Program.
Sara Dent Acosta is a Consumer Safety Officer from the Los Angeles District, San Diego Resident Post. She has been working with FDA since 1998. She conducts inspections in all food areas including Seafood HACCP, Juice HACCP, LACF, acidified foods and dietary supplements. She participated in the Draft Rule and Final Rule presentations for Dietary Supplement GMP's. She has a Master's Degree in Botany from the University of Puerto Rico, Mayagüez Campus and a MPh in Theoretical Ecology from the Department of Ecology and Evolution in SUNY Stony Brook. She has experience in tropical plant taxonomy and ecology.
James C. Griffiths, PhD is Vice President of Food and Dietary Supplement Standards at the US Pharmacopeia, in charge of dietary supplement and food ingredient issues and publications. Prior to joining USP, Dr. Griffiths was the Senior Toxicologist and Director of Toxicology and Business Development in the toxicology consulting firm of the Burdock Group, located in Vero Beach, Florida. Dr. Griffiths has a doctoral degree in Toxicology from Rutgers University and the University of Medicine and Dentistry of New Jersey, and post-doctoral work in physiological chemistry from the Heinrich Heine University in Düsseldorf, Germany. He has over 20 years of regulatory and safety experience, with the US FDA Center for Food Safety and Applied Nutrition, national trade associations (Distilled Spirits Council of the US and the Flavor and Extract Manufacturers Association), and end-use consumer companies with pharmaceutical excipient, food additive, flavor, cosmetic, and personal care product lines (International Specialty Products and Avon Products). Dr. Griffiths is a Diplomate of the American Board of Toxicology, a Fellow of the Institute of Biology, board certified in medical technology, and a member of the Society of Toxicology, Society of Toxicological Pathology, Society of Regulatory Toxicology and Pharmacology, the American College of Toxicology, and the Institute of Food Technologists.
Paul M. Hyman began his professional career in 1965 as a trial attorney in the Chief Counsel's Office of the U.S. Food and Drug Administration. In 1968, he entered private practice in Washington, D.C., with Kirkland and Ellis, where he became a partner. In 1976, he opened the Washington office of Rogers Hoge & Hills, remaining there until 1980, when this firm was established. Mr. Hyman is a graduate of the University of Chicago (1961) and Yale Law School (1965). He is admitted to practice in the District of Columbia and before the U.S. Supreme Court, and is a member of the American, District of Columbia and Federal Bar Associations. Mr. Hyman chaired the Federal Bar Association's Food and Drug Law Committee from 1972 to 1974. He was a member of the Board of Directors of the American Council on Science and Health from 1987 to 1989, and a member of the Editorial Advisory Board of the Food and Drug Law Journal from 1995 to 1997. He received a special recognition award from the Regulatory Affairs Professional Society in 1999, and the FDLI Distinguished Service and Leadership Award in 2003.
Matthew Knopp is the founding editor of Tablets & Capsules, the only magazine dedicated to the tablet and capsule processing industries. He has been involved in the powder and solids processing industries for more than 15 years.
Margaret Pazirandeh received her Bachelor of Science in Microbiology degree from San Diego State University, San Diego, CA and is certified in the National Registry of Microbiologists. She has more than 30 years experience as a Quality Professional in the pharmaceutical, medical device and dietary supplement industries. Margaret is the Director of Quality Assurance for Shaklee Corporation in northern California where she is responsible for internal quality assurance and cGMP activities as well as those required of their contract manufacturers.
She spent 16 years as Director of Quality Assurance and Quality Control at Pharmavite LLC. There she instituted the Standard Operating Procedures for Pharmaceutical manufacturing and worked on several teams to implement a quality management program. Margaret took the leading role in getting Pharmavite ready to pass the stringent standards of the USP Verification Program. Pharmavite was the first manufacturer to achieve compliance.
Ann Stahl is an Investigator with the Federal Trade Commission’s Western Regional Office, based in Los Angeles. She gathers evidence for the FTC’s consumer protection cases, and is also responsible for media relations and outreach for the regional office. Ms. Stahl has been with the FTC for 34 years, beginning as a Research Analyst in the Bureau of Consumer Protection in the agency’s Washington headquarters before transferring to the Los Angeles office in 1977.
Ms. Stahl also teaches a class in Consumer Advocacy and Education at California State University-Northridge. She holds a Master’s Degree in Public Policy and an A.B. in Political Science from the University of California at Berkeley.
Barry Titlow is the CEO of Compound Solutions, Inc., whose company focus is on concept, product and process development, as well as sales of active compounds to the pharmaceutical, nutritional supplement, food, and personal care industries. He has over 36 years experience in these areas with numerous contacts in the U.S., Europe and Asia which he visits regularly to inspect and consult.
Mr. Titlow has a BS degree in Zoology, with an extensive background in organic and biochemistry. He began his career as a research chemist for a major hydrocolloid manufacturer. Since then he has held various positions in technical services, technical sales, product development, and management, prior to founding Compound Solutions in 1998. He is a known speaker to industry, and is interviewed regularly by trade publications for his industry insights. Mr. Titlow was elected to the Board of Directors for AOAC International in 2006, helping to steer globally accepted analytical methodology. For AOAC, he has chaired the CoQ10 analytical committee and also chairs the Dietary Supplement Task Force.
John P. Venardos is the Vice-President of Worldwide Regulatory & Government Affairs for Herbalife International. He is a global regulatory affairs professional with over two decades of proven experience registering science-based food, food additives, supplements, cosmetics and pharmaceuticals in North and South America, Europe and Asia. At Herbalife, he leads staff based in Los Angeles, Washington, the EU, China, India and Australia in representing the company with regulators and government officials in 65 countries. He frequently interacts with regulators at HHS, ODS, FDA, FTC, Codex Alimentarius, ASEAN and DG-SANCO. Prior to joining Herbalife, John worked for Pfizer Inc. focusing on communications and regulatory affairs.
Ivan Wasserman, partner with Manatt, Phelps & Phillips, LLP, focuses on matters involving the marketing of foods, dietary supplements, cosmetics, drugs and medical devices. With extensive experience advising clients on the advertising and labeling of products such as these, which are subject to overlapping jurisdiction of the FDA and the FTC, he helps his clients develop creative approaches to meeting marketing objectives while staying within the constraints of applicable regulatory frameworks. In addition to advertising and labeling issues, Ivan's practice includes ingredient reviews and product formulation issues, responding to FDA warning letters, import detentions and product seizures, adverse event reporting and product recalls, and preparing new dietary ingredient notifications for supplements. Ivan has written articles for multiple industry publications and is a frequent and engaging speaker at industry workshops and events. Ivan has been recognized in The Best Lawyers in America for 2007-2008 and he earned his J.D. from The George Washington University.
David Xinchun Zhang is Founder & CEO of Shanghai Freemen LifeScience & Shanghai Freemen Americas. His also the Founder of Shanghai Freemen Chemicals. David Xinchun Zhang is one of the pioneers in China who has been manufacturing and distributing nutraceutical ingredients, especially Chitosan, Glucosamines, Ginkgo Biloba and etc., and he is the a majority owner of Shanghai Freemen and its subsidiaries today, active in the supply and development of ingredients for nutraceutical, functional beverage and food industries in North America, Europe and Asia.
Directions to the Rancho Las Palmas Resort
- From Palm Springs Airport (PSP): Turn left out of airport onto El Cielo, and then left at Ramon Road. Turn right at Bob Hope Drive. Resort is five miles on left.
- From Ontario International Airport (ONT): Drive east on I-10 to the Ramon Rd. / Bob Hope Drive exit. Turn right onto Ramon, and then take the next left onto Bob Hope Drive. Four miles to the resort.
- From Los Angeles International Airport (LAX): Drive east on I-10 to the Ramon Rd. / Bob Hope Drive exit. Turn right onto Ramon, and then take the next left onto Bob Hope drive. Four miles to the resort.
|