ESTRATEGIA REGULATORIA<\/h2>Jueves 10 de Septiembre<\/h3><\/div><\/div><\/div><\/div>\t\t\tObjetivo: concienciar que cuando se inicia una aventura empresarial, la estrategia regulatoria condiciona y tiene grandes repercusiones en la entrada en el mercado de la empresa. Normas regulatorias comunes. \u201cLeveraging Regulatory Strategy in Your Business Strategy\u201d Ascent Business Advisors<\/a> (Todd Snowden<\/a>), \u201cA successful regulatory strategy to optimize time to market\u201d Asphalion<\/a> (Lidia C\u00e1novas<\/a>), \u201cMarco regulatorio europeo para productos sanitarios\u201d Omologic<\/a> (Ezequiel Olmos<\/a>),<\/a> \u201cAspectos regulatorios aplicables a software como producto sanitario\u201d QTI<\/a>, (Marta Rodriguez<\/a>).<\/p>\n<\/div>\n\t\t<\/div>Video de la 1\u00aa Sesi\u00f3n<\/a><\/div><\/div>![\"\"](\"https:\/\/orange-rhinoceros-572136.hostingersite.com\/wp-content\/uploads\/2020\/09\/Meetup-Jueves-Regulatorios-Estrategia-Regulatorio-300x158.png\")
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\n\n\n\nIMPLANTACI\u00d3N REGULATORIA en FARMA<\/h2>Jueves 17 de Septiembre<\/h3><\/div><\/div><\/div><\/div>![\"\"](\"https:\/\/orange-rhinoceros-572136.hostingersite.com\/wp-content\/uploads\/2020\/09\/Meetup-Jueves-Regulatorios-Implantacion-Farma-2-300x158.png\")
<\/div><\/div>\t\t\tEjemplos pr\u00e1cticos de c\u00f3mo cumplir normas regulatorias europeas y americanas para poder poner tu medicamento en el mercado. \u201cExperiencias pr\u00e1cticas en el registro de instalaciones y medicamentos\u201d Rovi<\/a> (Julia M\u00aa Gonzalez<\/a>); \u201cHow to identify fast and cost-efficient strategies to get your products successfully authorized by Regulatory Agencies\u201d DDR<\/a> (Xavier Luria<\/a>); \u201cDesde Granada hasta la FDA\u201d IIDF Cabrera<\/a> (Juan Cabrera<\/a>).<\/p>\n<\/div>\n\t\t<\/div>Video de la 2\u00aa Sesi\u00f3n<\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div>\n\n\n\n
\n\n\n\nIMPLANTACI\u00d3N REGULATORIA en Diagn\u00f3stico<\/h2>Jueves 24 de Septiembre<\/h3><\/div><\/div><\/div><\/div>\t\t\tEjemplos pr\u00e1cticos de c\u00f3mo cumplir\u00a0 la norma propia regulatoria en Diagn\u00f3stico para el desarrollo de capacidades regulatorias:\u00a0 \u201cNovedades en la legislaci\u00f3n de productos sanitarios de diagn\u00f3stico in vitro\u201d AEFI y <\/a>\u00a0GENOMICA,<\/a>(Ascensi\u00f3n Hern\u00e1ndez<\/a>), \u201cPuesta en el mercado de un kit de PCR de COVID-19\u201d Vitro\u00a0<\/a>(Alberto Roncero<\/a>) \u201cTransici\u00f3n regulatoria de la l\u00ednea\u00a0 iVYDAL In Vitro Diagnostics\u201d Biomedal<\/a> (Virginia S\u00e1nchez<\/a>),<\/p>\nEl objetivo es permitir a las organizaciones garantizar el cumplimiento de las obligaciones regulatorias en constante cambio, gestionar el riesgo, aumentar la eficiencia y producir mejores resultados comerciales no es una tarea f\u00e1cil.<\/p>\n<\/div>\n\t\t<\/div>
Video de la 3\u00aa Sesi\u00f3n<\/a><\/div><\/div>![\"\"](\"https:\/\/orange-rhinoceros-572136.hostingersite.com\/wp-content\/uploads\/2020\/09\/Meetup-Jueves-Regulatorios-Implantacion-Diagnostico-3-300x158.png\")
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\n\n\n\nIMPLANTACI\u00d3N REGULATORIA en Dispositivos m\u00e9dicos<\/h2>Jueves 1 de Octubre<\/h3><\/div><\/div><\/div><\/div>![\"\"](\"https:\/\/orange-rhinoceros-572136.hostingersite.com\/wp-content\/uploads\/2020\/09\/Meetup-Jueves-Regulatorios-Implantacion-Dispositivos-Medicos-4-300x158.png\")
<\/div><\/div>\t\t\tEjemplos pr\u00e1cticos de c\u00f3mo cumplir la norma propia regulatoria en Dispositivos m\u00e9dicos para el desarrollo de capacidades regulatorias: \u201cMedical Devices: Practical examples of defining regulatory strategy through the FDA review process\u201d Eric Bannon<\/a>, \u201cOverview of Medical Devices Regulations in Europe\u201d Eduardo Garrido<\/a> (Asphalion<\/a>), \u201cSufficient Clinical Evidence for Clinical Evaluation Report\u201d Maria Ny\u00e5kern (AKRN Scientific Consulting<\/a>), \u201cBiotronic experience registering Medical Devices\u201d Francisco Rios (Biotronic<\/a>).<\/p>\n<\/div>\n\t\t<\/div>Video de la 4\u00aa Sesi\u00f3n<\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div>\n\n\n\nAdvanced Therapy Medicinal Products (ATMPs)<\/h2>Jueves 14 de Enero<\/h3><\/div><\/div><\/div><\/div>\t\t\tRegulatory implementation \/ enforcement in Advanced Therapy Medicinal Products (ATMPs), which are medicines based on genes, cells or tissues. Within this session we will talk about:<\/p>\n
\n- Regulatory framework for ATMPs<\/li>\n
- Regulatory considerations in the early development phase<\/li>\n
- Challenges of CMC (Chemistry, Manufacturing and Controls) in the development phase of cell therapy product<\/li>\n
- Marketing authorization procedure in EU<\/li>\n<\/ul>\n
The format of these meetups will be a theoretical part, accompanied by real experiences such as Alofisel, a pioneering drug for the treatment of one of the most serious complications of Crohn\u2019s disease. CSIC licensed Dr. Delgado’s invention to Tigenix\/Takeda, enabling the company to go on to develop Alofisel. Dr.Delgado will describe the drug development process at the L\u00f3pez Neyra Parasitology and Biomedicine Institute (IPBLN) run by the Spanish Council for Scientific Research (CSIC) \u00a0and based in the Granada Health Science Technological Park (PTS).<\/p>\n
Speakers:<\/p>\n
\u201cIntroduction to ATMPs and drug development\u201d <\/strong>Concepci\u00f3n Torrej\u00f3n<\/a> More than 11 years\u2019 professional experience across Europe mainly in Regulatory Affairs within the pharmaceutical industry including the multinational Takeda in London (UK).<\/p>\n\u201cTurning adult stem cells into a medicine: the researcher’s point of view” <\/strong>Mario Delgado<\/a> Neuroimmunology of Inflammatory and Autoimmune diseases Group Leader. Alofisel inventor. CSIC licensed Dr. Delgado’s invention to Tigenix\/Takeda, enabling the company to go on to develop Alofisel.<\/p>\n\u201cCMC challenges in the development of cell therapy products\u201d and \u201cMarketing Autorisation Procedure for ATMPs\u201d <\/strong>Maria A. Revieriego<\/a> Ex-regulator at the Medicine and Healthcare products Regulatory Agency (MHRA) in the UK as a Pharmaceutical Assessor of registration dossiers.<\/p>\n<\/div>\n\t\t<\/div>
Objetivo: concienciar que cuando se inicia una aventura empresarial, la estrategia regulatoria condiciona y tiene grandes repercusiones en la entrada en el mercado de la empresa. Normas regulatorias comunes. \u201cLeveraging Regulatory Strategy in Your Business Strategy\u201d Ascent Business Advisors<\/a> (Todd Snowden<\/a>), \u201cA successful regulatory strategy to optimize time to market\u201d Asphalion<\/a> (Lidia C\u00e1novas<\/a>), \u201cMarco regulatorio europeo para productos sanitarios\u201d Omologic<\/a> (Ezequiel Olmos<\/a>),<\/a> \u201cAspectos regulatorios aplicables a software como producto sanitario\u201d QTI<\/a>, (Marta Rodriguez<\/a>).<\/p>\n<\/div>\n\t\t<\/div> Ejemplos pr\u00e1cticos de c\u00f3mo cumplir normas regulatorias europeas y americanas para poder poner tu medicamento en el mercado. \u201cExperiencias pr\u00e1cticas en el registro de instalaciones y medicamentos\u201d Rovi<\/a> (Julia M\u00aa Gonzalez<\/a>); \u201cHow to identify fast and cost-efficient strategies to get your products successfully authorized by Regulatory Agencies\u201d DDR<\/a> (Xavier Luria<\/a>); \u201cDesde Granada hasta la FDA\u201d IIDF Cabrera<\/a> (Juan Cabrera<\/a>).<\/p>\n<\/div>\n\t\t<\/div> Ejemplos pr\u00e1cticos de c\u00f3mo cumplir\u00a0 la norma propia regulatoria en Diagn\u00f3stico para el desarrollo de capacidades regulatorias:\u00a0 \u201cNovedades en la legislaci\u00f3n de productos sanitarios de diagn\u00f3stico in vitro\u201d AEFI y <\/a>\u00a0GENOMICA,<\/a>(Ascensi\u00f3n Hern\u00e1ndez<\/a>), \u201cPuesta en el mercado de un kit de PCR de COVID-19\u201d Vitro\u00a0<\/a>(Alberto Roncero<\/a>) \u201cTransici\u00f3n regulatoria de la l\u00ednea\u00a0 iVYDAL In Vitro Diagnostics\u201d Biomedal<\/a> (Virginia S\u00e1nchez<\/a>),<\/p>\n El objetivo es permitir a las organizaciones garantizar el cumplimiento de las obligaciones regulatorias en constante cambio, gestionar el riesgo, aumentar la eficiencia y producir mejores resultados comerciales no es una tarea f\u00e1cil.<\/p>\n<\/div>\n\t\t<\/div> Ejemplos pr\u00e1cticos de c\u00f3mo cumplir la norma propia regulatoria en Dispositivos m\u00e9dicos para el desarrollo de capacidades regulatorias: \u201cMedical Devices: Practical examples of defining regulatory strategy through the FDA review process\u201d Eric Bannon<\/a>, \u201cOverview of Medical Devices Regulations in Europe\u201d Eduardo Garrido<\/a> (Asphalion<\/a>), \u201cSufficient Clinical Evidence for Clinical Evaluation Report\u201d Maria Ny\u00e5kern (AKRN Scientific Consulting<\/a>), \u201cBiotronic experience registering Medical Devices\u201d Francisco Rios (Biotronic<\/a>).<\/p>\n<\/div>\n\t\t<\/div> Regulatory implementation \/ enforcement in Advanced Therapy Medicinal Products (ATMPs), which are medicines based on genes, cells or tissues. Within this session we will talk about:<\/p>\n The format of these meetups will be a theoretical part, accompanied by real experiences such as Alofisel, a pioneering drug for the treatment of one of the most serious complications of Crohn\u2019s disease. CSIC licensed Dr. Delgado’s invention to Tigenix\/Takeda, enabling the company to go on to develop Alofisel. Dr.Delgado will describe the drug development process at the L\u00f3pez Neyra Parasitology and Biomedicine Institute (IPBLN) run by the Spanish Council for Scientific Research (CSIC) \u00a0and based in the Granada Health Science Technological Park (PTS).<\/p>\n Speakers:<\/p>\n \u201cIntroduction to ATMPs and drug development\u201d <\/strong>Concepci\u00f3n Torrej\u00f3n<\/a> More than 11 years\u2019 professional experience across Europe mainly in Regulatory Affairs within the pharmaceutical industry including the multinational Takeda in London (UK).<\/p>\n \u201cTurning adult stem cells into a medicine: the researcher’s point of view” <\/strong>Mario Delgado<\/a> Neuroimmunology of Inflammatory and Autoimmune diseases Group Leader. Alofisel inventor. CSIC licensed Dr. Delgado’s invention to Tigenix\/Takeda, enabling the company to go on to develop Alofisel.<\/p>\n \u201cCMC challenges in the development of cell therapy products\u201d and \u201cMarketing Autorisation Procedure for ATMPs\u201d <\/strong>Maria A. Revieriego<\/a> Ex-regulator at the Medicine and Healthcare products Regulatory Agency (MHRA) in the UK as a Pharmaceutical Assessor of registration dossiers.<\/p>\n<\/div>\n\t\t<\/div><\/div><\/div><\/div><\/div><\/div><\/div>\n\n\n\n
\n\n\n\nIMPLANTACI\u00d3N REGULATORIA en FARMA<\/h2>
Jueves 17 de Septiembre<\/h3><\/div><\/div><\/div><\/div>
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\n\n\n\nIMPLANTACI\u00d3N REGULATORIA en Diagn\u00f3stico<\/h2>
Jueves 24 de Septiembre<\/h3><\/div><\/div><\/div><\/div>
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\n\n\n\nIMPLANTACI\u00d3N REGULATORIA en Dispositivos m\u00e9dicos<\/h2>
Jueves 1 de Octubre<\/h3><\/div><\/div><\/div><\/div>
<\/div><\/div>Advanced Therapy Medicinal Products (ATMPs)<\/h2>
Jueves 14 de Enero<\/h3><\/div><\/div><\/div><\/div>
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![\"\"](\"https:\/\/orange-rhinoceros-572136.hostingersite.com\/wp-content\/uploads\/2020\/09\/ATMPs-RT-300x158-1.png\")
<\/div><\/div><\/div><\/div><\/div><\/div>\n\n\n\n![\"\"](\"https:\/\/orange-rhinoceros-572136.hostingersite.com\/wp-content\/uploads\/2020\/09\/Regulatorio6-300x150.jpeg\")
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