|
Updating on the evolving EU guidelines for pharmacovigilance to analyse the effect of these changing modules on the pharma and bio-pharma companies |
|
Understanding the regulatory landscape in the US with respect to submission requirements in pre-clinical, clinical development and post marketing pharmacovigilance studies to effectively comply with the FDA standards |
|
Meeting the stringent regulatory regime of Japan with respect to ADR, ICSR, PSURs and reporting processes to ensure compliance with PMDA standards |
|
Understanding the regulatory procedure in the Middle East and devising effective strategies to harmonise these procedures with the global requirements |
|
Overcoming challenges around meeting specific submission and reporting requirements in CIS countries and devising strategies for harmonisation with the Indian Pharmacovigilance standards |
|
Establishing specific pharmacovigilance requirements for special products and comparing them with the pharmacovigilance requirements for generics |
|
Updating on the Indian pharmacovigilance regulations and comparing them with EU, US and RoW countries to identify the differences and formulating best ways to comply with the PV regulatory environment globally |
|
Justifying the need and outcome of the new EU regulations to analyse their impact on the pharma companies. |
|
Justifying the need and outcome of the new EU regulations to analyse their impact on the pharma companies |
|
Understanding the role of pharmacovigilance in the early drug development stage to ensure a robust, well defined pharmacovigilance system throughout the pre-clinical and clinical development process |
