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As more pharma organizations collaborate, sharing their expertise, it is important that all parties are in agreement of their role and that a degree of compliance exists. Deepa Arora explains these agreements, which are better known as Safety Data Exchange Agreements.
Companies often collaborate to make best use of their specific expertise, as a result, there has been a significant increase in the collaborations, partnerships and licensing. Due to the involvement of more than one party, the responsibility for pharmacovigilance and thus, continuous assessment of the benefit risk analysis of the medicinal product may be overlooked, leading to non-compliance or it may happen that all of them are conducting various pharmacovigilance activities thus, causing the duplication of work.
Therefore, it’s critical to develop agreements to define the responsibilities of each partner for various activities. Such agreements are known as pharmacovigilance agreements or Safety Data Exchange Agreements (SDEA). SDEAs are written contracts developed between two or more pharmaceutical companies working together, to define the responsibilities of each party with reference to each pharmacovigilance activity. A well-drafted agreement ensures regulatory compliance and prevents the duplication of pharmacovigilance activities by various partners.
Pharmacovigilance agreements should be drafted to clearly define who will be responsible for the following activities:
Maintenance of Global safety database
Maintaining/ updating Company Core Safety Information
Case Processing including medical assessment and follow-up
Regulatory reporting of expedited cases
Preparation of PSURs and submission to various regulatory authorities
Literature searching & review
Signal detection & evaluation
Updating Summary of Product Characteristics / Package Inserts, Patient Information Leaflets/ Medication Guides and other relevant documents
Archiving of pharmacovigilance documents
Development, review, evaluation and implementation of Risk management plan
Continuous benefit-risk assessment
Urgent Safety Restrictions
Product complaints & Quality issues
Non approvals/ withdrawals related to safety
Responsibilities of Clinical trial reports, results of ongoing pre-clinical studies, conducting Post Authorization Safety Studies
Other regulatory actions related to the safety of medicinal products
For products authorized in Europe, SDEAs should also include responsibility of QPPv, role and responsibility for electronic reporting of ICSRs.
In addition, SDEAs should have definitions for clarity, key contacts of all partners, method of termination, date of next review and the territories covered by each partner. Where alliances extend to more than one country, the SDEA should define the responsibilities for each country. It should be signed and dated by all parties. SDEAs should clearly define the timelines for exchange of serious as well as non-serious adverse reactions. While serious adverse reactions are exchanged within 3- 5 calendar days, non-serious adverse reactions can be exchanged on a monthly or quarterly basis along with the reconciliation of serious adverse reactions. This will ensure that all non-serious cases are also appropriately included in the PSURs.
Business groups should inform pharmacovigilance teams of new associations, master agreements as well as change in the nature of partnerships or expiry/ cancellation of the master agreements in order to ensure timely preparation and appropriate implementation of the SDEAs. Pharmacovigilance staff should understand various types of commercial agreements and prepare SDEAs in line with these.
For companies that are entering in different types of collaborations with various companies, standard templates of SDEAs should be prepared. It will also be useful to develop a checklist to ensure that all relevant pharmacovigilance activities have been covered by the SDEAs. There should be processes in place to ensure that pharmacovigilance agreements are signed, training of the team responsible for execution of these agreements have been conducted and copies of these agreements are accessible to all responsible for pharmacovigilance. Inspectors also expect that companies should have the standard operating procedures (SOPs) and the templates for pharmacovigilance agreements.
During inspections, inspectors usually request for the list of SDEAs and thereafter, they may request for the copies of some executed agreements. Therefore, maintaining a ready list/ index of SDEAs comes quite handy at the time of pharmacovigilance inspections. Sometimes, during audits, the signed copy of the Pharmacovigilance agreement could not be found, although several drafts of pharmacovigilance agreements have been exchanged and there is a mutually agreed final draft too.
Although small companies with few agreements in place can manage with an excel sheet, for large companies that have hundreds of such agreements across the world, it will be useful to maintain a database of SDEAs along with reminders for periodic revision dates and alerts to revise these SDEAs in line with the changes in the local regulations. This database of SDEAs can also be linked with business groups and regulatory database to ensure that pharmacovigilance agreements are updated when the business agreement covers a new product or territory. Linking the database to regulatory database to enables the sharing of new package inserts and other regulatory actions with the partners.
SDEAs are legally binding as well as auditable documents. Failure to prepare the SDEAs, poorly drafted SDEAs and non-compliance with the executed SDEAs are some common inspection findings. Therefore, it’s important to pay due attention to the preparation and implementation of these SDEAs for efficient sharing of safety data as well as successful pharmacovigilance inspections.
Dr Deepa Arora is a Physician with more than 15 years of experience in drug safety and clinical development in the pharma industry and in academia. She has been in leadership and strategic roles in MNCs and Indian Pharma companies and successfully set up systems, developed teams and interacted with regulatory agencies in different regions including US, Europe, India and Australia. She has played an active role in developing awareness and skills of pharmacovigilance in the region by designing teaching modules for safety in medical institutions and training in pharmacovigilance workshops and courses. She is the author of the book “Pharmacovigilance- An Industry Perspective”. Deepa iscurrently working with Lupin Limited as the Global Head- Drug Safety & Risk Management.
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