An ever changing global regulatory environment, requires that the professionals of the biotech and pharmaceutical industries possess a strong foundation in pharmacovigilance. This demands ongoing, comprehensive and up-to-date training and education. We can help clients develop and implement customised corporate training plans that ensure teams acquire the adequate knowledge and develop the right capabilities to meet 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.