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Máster en Biotecnologia con mención en Global Project Management (VI Edición) ...

Máster en Biotecnologia con mención en Global Project Management (VI Edición) - Barcelona

Universidad de Barcelona and Biotechnology Business Institute

Máster presencial

Barcelona


12.900

Duración : 1 Año

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Sedes

Localización

Fecha inicio

Barcelona

Objetivos

The objective of the program is to acquire the knowledge in scientific and regulatory, from early stage to late stage drug development, achieving the new approvals and applying an international market access strategy. The main areas and topics are related with the regulatory agencies FDA and EMA, emerging markets, price & reimbursement, management of drug approvals and government affairs.

A quién va dirigido

The program is design for MSc and PhD with and with a high interest in science, willing to develop their career out the laboratory and the bench, in different management positions along the pharmaceutical industry such as in regulatory affairs department, market access, health economics, or government affairs among others. The program is focus in acquiring a global perspective in how a new drug in developed from the laboratory to the patient and the stakeholders involved.

Requisitos

Bachelor degree or PhD in Lifesciences; Biotechnology, Biochemistry, Bioengineering, Pharmacy, Biologist, etc.

Temario completo de este curso

GLOBAL ECOSYSTEM IN DRUG DISCOVERY
I. Biotechnology sector & Pharmaceutical industry
II. Intellectual Property and Strategy
III. Add Value & Unmet Need in Innovation
IV. Market Analysis Competitors in Development
V. Early Stage Licensing Agreements
VI. Public Funding for start-ups and spin-offs
VII. Early Market Access and Health Economics
VIII. Venture Funds and Late Stage Licensing

SCIENTIFIC AND REGULATORY DEVELOPMENT
I. Drug Discovery Process II. Target Product Profile (TPP)
III. Stakeholders in clinical and preclinical developments
IV. Preclinical and Clinical Development of Chemical compounds
V. Preclinical and Clinical Development of Biologic compounds
VI. Clinical Trial Design, Planification and Costs
VII. QXP’s and GMP’s during drug developments
VIII. Drug Registration Dossier for Approval FDA/EMA

PROFESIONAL AND PERSONAL DEVELOPMENT
I. Team Building
II. Leadership
III. Negotiation
IV. Management

PROJECT MANAGEMENT FOR NEW DRUG APPROVALS
I. Operational Model for Drug Discovery
II. Project Life Cycle and Portfolios
III. Project Management I
IV. Project Management II
V. Forecasting and Financial Plan
VI. Profit and Lost in new Products
VII. Medical Marketing and MSL
VIII. Marketing and Sales representative
IX. International Business development
X. Global Commercial Training
MARKET ACCESS AND HEALTHECONOMICS
I. Global Market Access Strategy
II. Local Market Access Strategy
III. National Healthcare Systems
IV. Premium Price and Shared risks
V. Heath Economics and Outcomes Research (HEOR)
VI. Budget Impact Analysis
VII. QUALY Adjustment VIII. Government Affairs
IX. Patients Associations
X. Health Technology Assessments (HTA’s)
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