TRAINING AND WORKSHOPS SERVICES
After the launch of the Pharmacovigilance Programme of India in 2010, Indian pharmacovigilance has progressed compared to how it used to be in the past. The Government of India is establishing a set of safety guidelines and regulations related to PV and RA processes. According to the regulations, all personnel involved in the performance of PV and RA -related activities within an organisation must receive initial and continued training. This training must relate to the roles and responsibilities of the personnel. Additionally, the organisation must ensure that all personnel are aware of appropriate instructions on the processes to be used in case of any urgency, including business continuity.
We provide bespoke training covering different aspects of PV and RA, in order to prepare you for a strong future in this new environment where it is mandatory to be compliant with the PV guidelines and regulations of India. We also cater to several international clients, and therefore have an expert team who is up-to-date with the continuously changing international guidelines, such as, ICH and EMA guidelines. Keeping in mind the domestic and international environments, the content of training courses and workshops can be tailored to suit your needs and requirements.
We offer various training courses and workshops in PV and RA that can help you to build your understanding in these areas. Some of the examples include:
- PV auditing;
- Preparing for audits and regulatory inspections;
- Basic foundation course for PV;
- Customised training on PV GVP Modules;
- Writing a case narrative;
- Establishing and implementing PV Quality Management System;
- Basic foundation course for RA;
- Software-based training on eCTD submissions;