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Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina): 2-day In-person Seminar

By:
Robert J. Russell, President of RJR Consulting, Inc.
Location 1:-
Spring Hill Suites New Orleans Downtown, LA

Monday, May 19, 2014 | Tuesday, May 20, 2014
Location 2:-
Courtyard Philadelphia Downtown, PA

Wednesday, August 20, 2014 | Thursday, August 21, 2014

Course "Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Course Description:

This two-day comprehensive Course on Latin America Regulatory compliance requirements will cover topics ranging from pre-clinical and clinical requirements through product registration, amendments and renewals across Pharmaceuticals, Biologics, Medical Devices and Combination Products. The Course will address the structure of the regulatory agencies in Latin America and discuss local cultural nuances to help you be successful in working with the regulators.


Why You Should Attend

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil and Mexico. Other countries such as Chile, Costa Rica, Dominican Republic, Panama, Peru and Venezuela will be discussed. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America. Content will include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of the wide array of licensed products.

The current regulatory climate in Latin America is discussed in detail and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues that have caused difficulties for Life Sciences firms in the region are outlined. Course content will explain how Latin America interacts with and utilizes ICH standards and how they relate with other National Healthcare Authorities. Additionally, participants will learn how personnel can best address the conflicts, which arise and the best course for resolution.


Who will Benefit

This course will be beneficial to:

  • Regulatory personnel whose responsibilities require knowledge of Latin America's regulatory environment
  • Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements will also find this training highly relevant.
  • QA / QC Personnel
  • Global Supply Chain personnel
  • Clinical / Pharma & Device personnel
  • Manufacturing personnel
  • Global Business Development personnel
  • Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization




Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  • LA Overview
  • LA markets
  • Harmonization efforts
  • Understanding the Regulatory Process
  • Regulatory Overview (gov't offices, organization, contact info)
    • Brazil - ANVISA
    • Mexico – COFEPRIS
    • Argentina – ANMAT
  • Country Establishment
  • Clinical Trials
    • Clinical Trial Start-up
    • Clinical Trial Application
    • IND's
    • Reporting
    • GCP
  • Scientific advice
  • Stability studies
  • Pharmaceuticals
    • Marketing Authorizations/Registrations
    • Registration requirements
    • Registration documentation/CTD
    • Summary of Product Characteristics
    • Package insert
    • Labeling
    • Pharmacovigilance/Post-marketing
    • Amendments/Variations/Changes/Renewals
    • Fees
  • Submission Process
  • Paper filings
  • Electronic filings

  • Generics & Bioequivalence
  • Biologics
  • Compassionate use
  • Orphan drugs
  • Medical Devices
    • Device Classification
    • Testing Standards
    • Registrations
    • Amendments/Variations/Renewals
    • Cost build-up model
    • Fees
    • Post-marketing
  • Combination products
  • Patents/Copyrights/Trademarks
  • Import/Export procedures
  • Tax exemptions
  • Advertising/Promotion
  • Comparing & Contrasting LA and US
  • Challenges in Latin America
  • Influencing the Regulatory Process
  • Conclusions & summary





Meet Your Instructor

Robert J. Russell
President of RJR Consulting, Inc

Robert J. Russell, (Bob) is the President of RJR Consulting, Inc., a Global Regulatory Consulting company, specializing in understanding regulatory issues for the pharmaceutical, medical device and combination products industry. Bob has more than 30 years of experience working with FDA, EMA, Healthcare Authorities and Agencies across Latin America, Middle East and Asia / Pacific supporting clients projects in these regions. Licensing, registrations, GMP, DMFs and borderline products are core competencies of the Course Director.

Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 manufacturers of Drugs and Medical Devices. RJR's offices are located in every major region with in-country experts on staff handling local regulatory needs. Bob has a BS and MS in Chemistry.





Register Online

$1,399.00

Seminar One Registration

May 19-20, 2014, New Orleans, LA
(Early bird price valid till April 25, 2014)
Actual Price: $1,599

$6,599.00
$8,394.00
You Save: $1,795.00(21%)*

Special Group Discount Register for Six attendees

May 19-20, 2014, New Orleans, LA
*Hurry! This option is limited and based on availability.
Great Saving with Group Ticket!!! Only 3 left

$1,599.00

Seminar One Registration

August 20-21, 2014, Philadelphia, PA


Register Now and Save $200 (Early Bird Price)
For Registrations till April 25, 2014 $1,399
Actual Price $1,599
Early Bird Seats are limited and based on first-come, first-serve.

The registration fee includes: the workshop; all related course materials; morning tea/coffee lunch and afternoon tea/coffee on both days


For discounts on multiple registrations, contact customer care at +1-888-717-2436

Register by P.O. / Check


Yes, I want to attend "Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina): 2-day In-person Seminar"

If you are paying by check:

Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
2600 E. Bayshore Road
Palo Alto, CA 94303
USA

Group Registrations

Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

2 Attendees - Get 10% off
3 to 6 Attendees - Get 20% off
7 to 10 Attendees - Get 25% off
10+ Attendees - Get 30% off

Register by Wire Transfer




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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 @ editor@complianceonline.com

Payment:
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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Venue

Location 1:

Special Offer for the attendees of this seminar:

Rooms available at only $109 per night.

Please note: Hotel rooms are limited and based on availability




View Larger Map


How to Reach

Driving Directions:

From Louis Armstrong New Orleans International Airport – MSY: 14 mile(s) E
  • Follow Airport signs to I-10E and proceed 7 miles.
  • Take the 90 Business West exit and proceed 4 miles, to the Tchoupitoulas / S. Peters exit.
  • At the second traffic light turn left onto Tchoupitoulas Street.
  • Follow to St. Joseph and turn right. Hotel is on left.

Other Transportation:

Bus Station
  • Greyhound: 1 mile(s) W

Train Station
  • Amtrak Station: 1 mile(s) W

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.



Location 2:



View Larger Map


How to Reach

General Driving Directions:

Driving Directions from Philadelphia International Airport – PHL: 10 mile(s) SE
  • Take Interstate 95 North to Interstate 676 West
  • Exit at Broad Street (Route 611)
  • Stay in the left lane and take the first left turn onto Vine Street
  • Continue on Vine Street to 12th Street and turn right
  • Proceed to Market Street and turn right
  • Follow Market Street toward City Hall and the hotel will be on the right immediately after the first traffic light.

Other Transportation:

Bus Station
  • Greyhound Bus Lines: 0.3 mile(s) E

Subway Station
  • 13 St Station: 0.1 mile(s) SE
  • Blue Line: 0.1 mile(s) S

Train Station
  • Amtrak-PHL: 1.2 mile(s) W

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.




Testimonials

Regulatory landscape for pharmaceuticals in Brazil and Mexico topic was most valuable. Overall it was good seminar. It gave me a comprehensive view on the ins and outs of registration in LA. I like the scale of the event that makes it very focused and interactive.
- Head Clinical Pharmacology and Bioanalytics, Abbott Healthcare Products B.V

The speaker was excellent and knowledgeable with topic. Understanding the regulatory process and registration requirements topics were useful to me.
- Associate Director, Purdue Pharmaceuticals

The presenter was very knowledgeable and interaction between participants and presenter was good.
- International Regulatory Affairs Associate, Bard Access Systems, Inc.

The subject matter was very well presented and design of the presentation was appropriate.
- Manager of Quality Assurance & Regulatory Affairs, Keystone Industries, Inc.

The presenter was very knowledgeable. Medical device registrations and export/import topic was most valuable to me.
- International Regulatory Program Manager, Asuragen, Inc.

The presenter was very knowledgeable. The questions were answered quickly. Medical device topic was very informative.
- RA Specialist III, Moog Inc.

Bob was a great instructor, very helpful. Thanks to ComplianceOnline.com for conducting this seminar, Medical Device companies always need to be compliant so guidance/updates are always needed. I would recommend ComplianceOnline.com to others. Thanks!
- Manager, Clinical Operations, Clovis Oncology

This seminar had great overview and introduction to Japan & S. Korea regulatory and clinical environment. Medical Device related material was most valuable for me as it is most aligned with my work. The amount of interaction between the participants and presenter was ideal. I would like to attend future seminar on "Regulatory and Clinical for Latin American countries".
- Director of Global Product Safety, Kimberly-Clark Corporation

Understanding the regulatory structure in the countries and how they interact, was the most valuable topic for me. Overall it was a good seminar - I learned a lot. Enjoyed the informal nature and being able to ask questions as went along. I would like to give thanks to ComplianceOnline for good customer service on the phone.
- Clinical Project Manager, Global Clinical Affairs, Kimberly-Clark Corporation

Overall it was a good course for Japan/S. Korea familiarity. More content on device, more discussion using application of data in real life scenarios, and less straight reading slides. I would like to attend future conferences on "Medical Device Tech Files" and "Medical Device Directives & Essential Requirements".
- Regulatory Affairs Specialist, I-Flow, LLC

ComplianceOnline website was helpful and informative for the conference. I like the areas covered on "Identification of regional differences, and regulations & processes". subject was well chosen and overall it was good experience.
- Sr. Director, Gilead

This course was offered by ComplianceOnline and it was excellent. Bob is very knowledgeable and have answered all my questions. I like the knowledge delivered on Clinical, however, got a lot more on other topics as well. Good Summary. I would like to attend future seminars on China and Latin America.
- Sr. Director of Regulatory Affairs, STAAR Surgical

Instructor was very knowledgeable on topic. Length of the program was appropriate. I like the session of overall submission process. I would like to attend future seminars on China & Asia, and BRIC.
- Regulatory Affairs Specialist, I-Flow, LLC

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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  • Article on the Magazine and/or Website after the conference.

 




New Orleans, LA, Local Attractions

Philadelphia, PA , Local Attractions

Welcome to the birthplace of jazz, New Orleans. Every night of the week, the streets and clubs of the Big Easy are still alive with vibrant music. From traditional jazz to acid jazz, there's something for every ear, every day of the week.




With over 45 museums throughout the city to choose from, it's easy to immerse yourself in the city's history, culture and arts.




One block over from the raucousness of Bourbon Street is the French Quarter’s more refined and elegant epicenter of local artistic culture. Royal Street is an eye-pleasing mix of classy antique shops and boutiques, fine jewelry stores, colorful art galleries and world-class hotels and restaurants.




There’s a reason so many visitors flock to the French Quarter every day – both locals and tourists can’t get enough of the unique area’s unique attractions. From the beautiful architecture to art galleries, museums, restaurants, and bars, the French Quarter has something for everyone – no matter what your interests, budget, or age may be. Join up with a tour and learn more about the fascinating history of the area, or spend the entire day exploring and shopping in the area, topping everything off with an excellent meal in a world-famous restaurant and some live music. With so much culture, history, and entertainment, you’ll find a unique and exciting experience around every corner.




Although this historic French Quarter street has a bawdy reputation due to the burlesque clubs and all-night partying, come experience a whole other side of Bourbon Street steeped in history, folk lore and beauty that dates back to 1718 when New Orleans was founded by Jean-Baptiste Le Moyne de Bienville. Also known as “Rue Bourbon,” this historic street sits at the heart of the French Quarter extending 13 blocks from Canal St. to Esplanade Avenue.




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.




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 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.




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.”







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