NY/NJ Chapter Webcast: BRAZIL's 5 Year Journey as an ICH Member; what has changed, challenges and opportunities, and influence on other LATAM countries

1.0
RAC Credits
Chapter Events Chapter Events
Friday, 13 May 2022 (12:00 PM) - Friday, 13 May 2022 (1:00 PM) Eastern Time (US & Canada)

Member: $0
Nonmember: $25


This presentation will provide an overview of the five years (2016 to 2021) since ANVISA became a member of ICH. Topics to be discussed include the implementation status of key ICH guidelines, such as M4 (CTD), Q1 (stability), and Q12 (post-approval changes), and challenges and opportunities of being a "new member" of ICH. At the end of the presentation, we will cover an overview of ICH in other LATAM markets and how this regulatory convergence effort is paving the way for implementing reliance mechanisms in LATAM.

A live Q&A portion with the speaker will follow the presentation.

This event is brought to you by RAPS NY/NJ Chapter  to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.

Learning Objectives

Participants will:

  • Develop a better understanding of the evolving regulatory landscape in Brazil
  • Understand the implications of ICH guidance in Brazil
  • Understand regulatory convergence and ICH in other LatAm markets

Who Should Attend?

Industry personnel involved in Regulatory Affairs and Quality Assurance roles.

Audience Learning Level

Learning Level: Intermediate 

Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speakers will follow the presentation. 

RAPS Membership

RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Find out more about RAPS membership today.


Featured Speaker:

Juliana Rocha, Partner at N.G. Reis Consultoria Ltda, São Paulo, Brazil

Juliana Rocha is a partner at N.G. Reis Consultoria Ltda, São Paulo, Brazil. She is a pharmacist with more than 15 years of regulatory affairs experience. She has extensive experience in global regulatory affairs, having managed preparation of submissions to more than 50 countries, spanning the US, EU, APAC countries and Latin America. Rocha currently provides consulting services to biopharmaceutical companies, applying her global experience in evaluating new regulations in Brazil. She also performs in-company training related to regulatory pathways and CTD dossiers.

Thank you to our Platinum Chapter Sponsors:




Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing to raps@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the webcast.

Questions

Contact the RAPS Support Center:

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org

Discover more of what matters to you

News »

  5;10;16;17;25;30;