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. “Leveraging Regulatory Strategy in Your Business Strategy” Ascent Business Advisors (Todd Snowden), “A successful regulatory strategy to optimize time to market” Asphalion (Lidia Cánovas), “Marco regulatorio europeo para productos sanitarios” Omologic (Ezequiel Olmos), “Aspectos regulatorios aplicables a software como producto sanitario” QTI, (Marta Rodriguez).

Ejemplos prácticos de cómo cumplir normas regulatorias europeas y americanas para poder poner tu medicamento en el mercado. “Experiencias prácticas en el registro de instalaciones y medicamentos” Rovi (Julia Mª Gonzalez); “How to identify fast and cost-efficient strategies to get your products successfully authorized by Regulatory Agencies” DDR (Xavier Luria); “Desde Granada hasta la FDA” IIDF Cabrera (Juan Cabrera).

Ejemplos prácticos de cómo cumplir  la norma propia regulatoria en Diagnóstico para el desarrollo de capacidades regulatorias:  “Novedades en la legislación de productos sanitarios de diagnóstico in vitro” AEFI y  GENOMICA,(Ascensión Hernández), “Puesta en el mercado de un kit de PCR de COVID-19” Vitro (Alberto Roncero) “Transición regulatoria de la línea  iVYDAL In Vitro Diagnostics” Biomedal (Virginia Sánchez),

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 fácil.

Ejemplos prácticos de cómo cumplir la norma propia regulatoria en Dispositivos médicos para el desarrollo de capacidades regulatorias: “Medical Devices: Practical examples of defining regulatory strategy through the FDA review process” Eric Bannon, “Overview of Medical Devices Regulations in Europe” Eduardo Garrido (Asphalion), “Sufficient Clinical Evidence for Clinical Evaluation Report” Maria Nyåkern (AKRN Scientific Consulting), “Biotronic experience registering Medical Devices” Francisco Rios (Biotronic).

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:

• Regulatory framework for ATMPs
• Regulatory considerations in the early development phase
• Challenges of CMC (Chemistry, Manufacturing and Controls) in the development phase of cell therapy product
• Marketing authorization procedure in EU

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’s 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 López Neyra Parasitology and Biomedicine Institute (IPBLN) run by the Spanish Council for Scientific Research (CSIC)  and based in the Granada Health Science Technological Park (PTS).

Speakers:

“Introduction to ATMPs and drug development” Concepción Torrejón More than 11 years’ professional experience across Europe mainly in Regulatory Affairs within the pharmaceutical industry including the multinational Takeda in London (UK).

“Turning adult stem cells into a medicine: the researcher’s point of view” Mario Delgado 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.

“CMC challenges in the development of cell therapy products” and “Marketing Autorisation Procedure for ATMPs” Maria A. Revieriego Ex-regulator at the Medicine and Healthcare products Regulatory Agency (MHRA) in the UK as a Pharmaceutical Assessor of registration dossiers.

• Begin developing your regulatory strategy when you move from discovery to developing or when in-licensing
• Non clinical needs for new product development 
• Regulatory needs for early-stage companies/researchers
• Medicinal product development regulatory interactions

The format of these meetups will be a theoretical part, accompanied by real experiences.

Jessica Monrás Successful Inside Sales Manager with over eighteen years of pharmaceutical early development experience. Strong expertise in fostering connections between nimble biotech companies and CROs subject matter experts. 10 minutes introduction. 

Paul Baldrick is Executive Director, Regulatory Strategy within Global Regulatory Affairs at Covance, has over 30 years in nonclinical development and regulatory strategy (CRO, UK and Belgium industry). Providing high-level regulatory/nonclinical consultancy support for pharmaceuticals, biotechnology products, vaccines and medical device.