THIRD PARTY QUIRES AND POST APPROVAL CHANGES

THIRD PARTY QUIRES AND POST APPROVAL CHANGES

About the course:-

Handling and solving the regulatory queries raised by healthcare authoritiestimely manner to the Regulatory Agencies and submitting post approval changes on behalf of third part is the main objective of this training.

Objective of the course:-

THIS PROGRAMME HELPSIN COENSURING THE RESOLVMENT OF QUIRESRECEIVED FROM AGENCIES AND INFORMING POST APPROVAL CHANGES TO THE AUTHORITIES

Course Syllabus

Topic : 1 THIRD PARTY QUIRES AND POST APPROVAL CHANGES

Sadhanainfotech strives to achieve complete client satisfaction, we assist our customers in handling and solving the regulatory queries raised by healthcare authorities. We also provide query responding services. Our salient features include the following:

• Assistance in timely Query-Response to the Regulatory Agencies – Review of queries, timely correspondence with agencies, discussion, planning and follow-up with the clients for the generation of additional data as required.
• Response preparation and timely submission of query responses to health authorities.

Topic : 2 Post approval changes

In order to attain the drug product approval from the agencies any quires/ deficiencies need to be effectively responded to gain the approval. After receiving the approval or during commercialization of the drug product, if manufacturers realize and propose any changes (administrative/quality) to the registered content (that is dossier), those shall be informed to Health Authority (HA) by filing supplements or variations or amendments, which are referred as post-approval changes. Based on the impact, these changes are categorized further according to agencies.