What you must know about the
new API legislation in Brazil
and how the process compares between Latin America and Europe
Tuesday, September 14th, at 6pm CET (Convert to your time zone)
Brazil’s regulatory authority, Anvisa, made changes to its framework for registration of active pharmaceutical ingredient (API). The new resolutions change the dynamics currently established and now, for the first time, a foreign company, without a National Registry of Legal Entities (CNPJ), will be able to petition in Anvisa's systems for the purpose of a documental approval.
This specific webinar will give you an updated presentation of the API registration process in Brazil, so you can better prepare your application. Our expert speaker will also make relevant comparisons with the European process as to enrich and boost your perspective of the current regulatory demands for the Pharmaceutical industry.
WHO SHOULD ATTEND
Import & Export Department
Ana Luisa Fritschy
Ana Luisa Fritschy is a Regulatory Affairs Manager with 20 years of experience with Health Authorities and in the Pharmaceutical Industry. She gained great knowledge and international expertise in the development and registration of drugs, medical devices, transfer of marketing authorisation, consultation with authorities and other aspects related to the establishment of new subsidiaries, especially in Latin American countries such as Brazil, Mexico, Argentina and Peru.
PAST OLA EVENTS
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Speakers did an overall comparison between local labelling legislations at different levels, discussed mandatory particulars, prohibited claims and suggested labelling compliance strategies before entering the desired market.
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Eliana Silva de Moraes
Eliana Silva de Moraes has almost 30 years of expertise in food law, helping international food companies to gain presence in markets of Latin America and Europe. An active participant in the harmonization of the regulatory affairs process, she played a role in setting up Brazil’s Public Health Regulator (ANVISA). President of the ABPVS and General Director of OLA Experts, the Latin American Organization for Research and Training in International Regulatory Affairs.
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This webinar was a talk with Raquel Busnello, a headhunter who works as an interface between companies and professionals, looking for potential candidates to fill international positions in Europe and Latin America. We also heard from professionals who took the plunge and have successfully transitioned to their international careers about their experience and advices:
Elaine Bernardino, Senior Lider Counsel - Global Functions at Sandoz International
Maria Regina Shimizu, International Consultant
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