Training

Today’s rapidly changing global regulatory environment requires that the professionals of the bio- and pharmaceutical industries possess a strong foundation in pharmacovigilance. This demands ongoing, comprehensive, and up-to-date training and education. Viglya helps clients develop and implement customized corporate training plans that ensure teams acquire the adequate knowledge and develop the right competencies and attitudes to meet daily challenges successfully.

Training on Company Procedures

Design of continuous training programs in pharmacovigilance and regulatory affairs.

Generation and delivery of tailor-made, on-site training on drug development, pharmacovigilance, and regulatory affairs.

Assistance with developing interactive workshops (remote training packages; training manuals).Guidance and support in implementing online training based on client’s internal processes, systems, and requirements.

Training on Current Legislations and Guidelines (Europe, ICH, U.S.)

Pharmacovigilance modular training for pharmacovigilance staff (all responsibility levels) and for non pharmacovigilance-staff:

Regulatory Affairs training: in depth or tailor-made training on key regulatory aspects of interest (eg, requirements for opening an IND in the U.S.).

Mentoring and Coaching of Staff

Training, mentoring, and coaching of staff on specific regulatory and pharmacovigilance activities (budding EU QPPV, junior and senior staff) in support of professional development.

Preparación para la Inspección de Autoridades Regulatorias

Realización de inspecciones simuladas (‘mock inspections’) y preparación ante la inspección.

Diseño y realización de formación para la preparación de inspecciones, incluyendo logística, entrevistas y juegos de rol.

Asesoría acerca de la coordinación de la inspección y su gestión.

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