CMC Strategy Forum Latin America 2021 - ENGLISH
Aug 11, 2021 10:30am ‐ Aug 11, 2021 2:00pm
Session Speaker(s):
- Nadine Ritter, Global Biotech Experts, LLC
- Joseph Kutza, AstraZeneca
Session Chair(s):
- Cammilla Horta Gomes, Produtos Roche Químicos e Farmacêuticos S.A.
- Ana Padua, Merck Serona S.A.
- Juliana Perlow, MSD
- Claudia Saidman, ANMAT-National Administration of Medicines, Food and Medical Technology
- Susan Zavala Coloma, DIGEMID-General Directorate of Medicines, Supplies and Drugs
Session Speaker(s):
- Maria Cecilia Tami, Genentech, a Member of the Roche Group
- Jason Fernandes, Health Canada
- Fernando Goldbaum, Inmunova S.A.
- JR Dobbins, Eli Lilly and Company
- Holger Raviol, F. Hoffmann-La Roche Ltd.
Panel Member(s):
- Iván Omar Calderón Lojero, COFEPRIS, Federal Commission for the Protection from Sanitary Risks
- Carla Elizabeth Chavez Cancino, DIGEMID-General Directorate of Medicines, Supplies and Drugs
- Jennifer Eck, AstraZeneca
CMC Strategy Forum Latin America 2021 - SPANISH
Aug 11, 2021 10:30am ‐ Aug 11, 2021 2:00pm
Session Speaker(s):
- Nadine Ritter, Global Biotech Experts, LLC
- Joseph Kutza, AstraZeneca
Session Chair(s):
- Cammilla Horta Gomes, Produtos Roche Químicos e Farmacêuticos S.A.
- Ana Padua, Merck Serona S.A.
- Juliana Perlow, MSD
- Claudia Saidman, ANMAT-National Administration of Medicines, Food and Medical Technology
- Susan Zavala Coloma, DIGEMID-General Directorate of Medicines, Supplies and Drugs
Session Speaker(s):
- Maria Cecilia Tami, Genentech, a Member of the Roche Group
- Jason Fernandes, Health Canada
- Fernando Goldbaum, Inmunova S.A.
- JR Dobbins, Eli Lilly and Company
- Holger Raviol, F. Hoffmann-La Roche Ltd.
Panel Member(s):
- Iván Omar Calderón Lojero, COFEPRIS, Federal Commission for the Protection from Sanitary Risks
- Carla Elizabeth Chavez Cancino, DIGEMID-General Directorate of Medicines, Supplies and Drugs
- Jennifer Eck, AstraZeneca
Business Continuity During and After the Pandemic: What Lessons Can Be Taken to the Future? - ENGLISH
Aug 12, 2021 10:30am ‐ Aug 12, 2021 1:40pm
The ongoing COVID-19 pandemic poses challenges to all National Regulatory Authorities (NRAs) and industry in the short, medium and long term. In LATAM, where there are differing capacities, resources and infrastructure across NRAs, several potential challenges and issues impact regulatory processes in different levels. Many solutions were already applied by some NRAs to minimize the pandemic impacts, avoid shortages and maintain business continuity, as the use of expedited pathways, reliance procedures, local quality control exemption for imported products and different digital solutions, such as virtual meetings, virtual inspections, e-CPP, e-GMP, e-labeling and electronic submissions. Some important lessons can be taken by this unprecedented situation, which may provide an opportunity for Regulators and Industry to strengthen their regulatory systems and implement the Best Regulatory Practices in a long term.
Session Chair(s):
- Daniela Manzoli Bravo, Bayer S.A. – Brazil
Speaker(s):
Session Chair(s):
- Kavita Aiyer, Seagen Inc.
- Maria Cristina Mota Pina, AbbVie, Inc.
- Maria Cecilia Tami, Genentech, a Member of the Roche Group
Session Speaker(s):
- Ihatanderson Alves da Silva, ANVISA-National Health Surveillance Agency
- Stephan Rönninger, Amgen (Europe) GMBH, Switzerland
- Rebecca Lumsden, Pfizer Limited, United Kingdom - representing FIFARMA
Panel Member(s):
- Patriciá Aprea, ANMAT- National Administration of Medicines, Food and Medical Technology
- Iris Lorena Arreola Dominguez, COFEPRIS-Federal Commission for the Protections from Sanitary Risks
- Miguel Angel Sare Cruz, DIGEMID-General Directorate of Medicines, Supplies and Drugs
Business Continuity During and After the Pandemic: What Lessons Can Be Taken to the Future? - SPANISH
Aug 12, 2021 10:30am ‐ Aug 12, 2021 1:40pm
Speaker(s):
Session Chair(s):
- Daniela Manzoli Bravo, Bayer S.A. – Brazil
- Kavita Aiyer, Seagen Inc.
- Maria Cristina Mota Pina, AbbVie, Inc.
- Maria Cecilia Tami, Genentech, a Member of the Roche Group
Session Speaker(s):
- Ihatanderson Alves da Silva, ANVISA-National Health Surveillance Agency
- Stephan Rönninger, Amgen (Europe) GMBH, Switzerland
- Rebecca Lumsden, Pfizer Limited, United Kingdom - representing FIFARMA
Panel Member(s):
- Patriciá Aprea, ANMAT- National Administration of Medicines, Food and Medical Technology
- Iris Lorena Arreola Dominguez, COFEPRIS-Federal Commission for the Protections from Sanitary Risks
- Miguel Angel Sare Cruz, DIGEMID-General Directorate of Medicines, Supplies and Drugs