Masterclass on Pharma Risks for Drug, Device or Dossier

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Event Details

Masterclass on Pharma Risks for Drug, Device or Dossier - May 29, 2018

By popular demand, Bombay Chamber is happy to announce a second instalment of the ever popular Pharma Masterclass.  This masterclass is designed to give practical and product knowledge to senior management from the pharmaceutical industry. 

Context :

In a time of ever changing global dynamics, the Pharmaceutical Industry has been at the forefront of complex litigation.

Never has the requirement for understanding critical risks and liabilities been more important than it is today. It is therefore the need of the hour to understand and analyse the risks involved, structure solutions for these risks including alternative risk transfer.

Objectives :

  • To understand and analyze the risks and liabilities that the Pharmaceutical Industry is exposed to.

  • To be able to implement end to end Contract Management solutions with regard to risk.

  • To prepare and present Risk Report and Dashboards to the Management

  • To be equipped to structure, address and mitigate the Pharma risks

Topics Covered :

1. Risk Analytics for Products, Devices & Services

  • Understanding of Liabilities that could arise for each product, device, service given their specific nature and profile

  • Analysis of risks arising out of gaps in Quality Control

  • Label Manufacturing Risks

  • Supply Chain Management Risks


2. Regulatory Considerations affecting Organization Risk
  • Analyzing the changing Regulatory Framework

  • Structuring the Addressing of Regulatory Requirement in the DNA of the Organization

  • Understanding of the Peculiar Risks posed by Regulators Framework and the potential non-indemnification of the same by traditional channels


3. The Optimal Pre-emptive Contract Management
  • Need for overall review of the contract by the Risk Management Team

  • Indemnification vs. Insurance Coverage

  • Limiting the Liability & Need for End to End Contract Management as well as recourse from third parties


4. The Complete Healthcare solutions  ( blended product)
  • Premises & Operations (Public Liability)

  • Product Liability and Clinical Trials

  • Profile of the Product Portfolio

  • Coverage Analysis & Contractual Obligations including contractual obligations for Recall & Extended Reporting Period

  • Country Specific Requirements

  • Adherence required to contractual obligations

  • Exclusion List Validation

  • Excluded Products & Coverage Management for the same


5. Structuring the Risk Profile
  • Risks that can be indemnified through Insurance

  • Risks that need to be handled through the Balance Sheet 

 

6. Dashboard Management & Training 

Ms. Anisha Udeshi, Director- Insurance and Risk Management, Cipla Ltd.

Ms. Jui Buch, Specialist Consultant

Ms. Uttara Vaid, Founder, Uttara Vaid Advisory

 Board Room, Bombay Chamber, The Ruby, NW-4th Floor, Dadar (W), Mumbai – 400028

Ashwini Ghogare

Tel : 022 61200238, 9004100768

Lysha Lewis
Tel : 022 61200234, 9819748882

Participation Fee :   

Members  Rs. 3500 + 18% GST
Non-Members  Rs. 4000 + 18% GST

 

Bank Details for NEFT

Account No.

02422418061924

IFSC CODE

DCBL0000024

Bank Name

DCB Bank

Branch Address

Mahim (024), Mumbai

Cheque /Demand Draft should be drawn in favor of “BOMBAY CHAMBER OF COMMERCE AND INDUSTRY”.

EVENTS

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