JOANA PAMA REIS regulatory affairs

Lisbon • Portugal

making your job easy.

Joana Pama Reis is a senior independent Regulatory Affairs Consultant, based in Portugal, with over a decade of experience.

Throughout her career Joana Pama Reis has worked with: GSK, Pierre Fabre, Delta Rottapharm, 3M, Machado Malcher, Laboratórios Effik, HRA Pharma, Regulatory Pharma Net, Brand 75.

Intr

oduc

tion

Joana Pama Reis obtained her Degree in Pharmaceutical Sciences with the Faculdade de Farmácia da Universidade de Coimbra in 1998. Gained a Post-graduation in Medicine and Pharmacy Law with the Faculdade de Direito da Universidade de Coimbra in 2002. Culminating in over a decade of experience in Pharmaceutical Regulatory Affairs. Comprehensive experience in relationship management, through a range of businesses, from small to multinationals both in Portugal and Internationally.

Abou

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Personal, independent and confidential support in all phases of the project. Complete dedication to ongoing projects. Adaptation to your needs and structure, regarding company meetings and work internally and externally. Guarantee of scrupulous fulfillment to all agreed deadlines and budgets.

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lity

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New MA applications and MA maintenance New MA applications – Preparation, submission and maintenance (national, mutual recognition, decentralized and centralized procedures, in NeeS and eCTD format) Compliance MA renewals Variations Type IA, type IB and type II MAH transference MA dossiers Elaboration/Revision SPC PIL and labeling revision Connection with the health authorities Prices and Reimbursement Price – new requests and revisions Reimbursement Marketing Revision of marketing materials Notification of the marketing materials to the health authorities Pharmacovigilance Periodic Safety Update Reports Development of Pharmacovigilance Procedures Manual Licensing of Distributors Medicine Distribution authorisation application Medical Devices Distribution authorization application Elaboration and implementation of SOPs Medical Devices and other products Medical Devices | Cosmetic | Food Supplements Elaboration and revision of labeling and instructions for use Notification to local authorities Other Support in company meetings, internally and externally Medical Sales Representatives registration Training Translation of scientific papers

Serv

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Joana Pama Reis Regulatory Affairs Consultant Lisbon | Portugal mobile: +351 919244546 | e-mail: info@pamareis.com | web: www.pamareis.com

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