DCVMN 3Rs Working Group
Operational Approach and Objectives
Laura Viviani
Nora Dellepiane
Sonia Pagliusi
Background for the creation of the 3Rs WG
During May 2018, DCVMN organized a first workshop in Hyderabad aimed to inform all members on alternative methods for vaccine testing. [1] Further follow-up workshop was held in June 2019 in Hyderabad to discuss with interested manufacturers and their role in advancing the 3Rs agenda.
Fifteen DCVMN member companies and a total of 62 participants attended the workshop, the majoritarian representation was from companies based in India but also companies from Bangladesh, Vietnam, Thailand, Indonesia and China joined the workshop. The target audience included professionals either performing, supervising, managing, auditing, or overseeing the validation of vaccine testing methods for the quality control of vaccines and biopharmaceutical products. It included professionals from a variety of areas such as Analytical Development, Quality Control, Quality Assurance, Validation groups, Senior Management, Project Managers and Regulatory Affairs professionals responsible for the strategic alignment of local and global operations.
The main outcomes of the workshop were:
Participants have also mentioned the conditions they felt would be required to engage their respective companies in participation in collaborative studies aimed at implementing alternative methods, such as those proposed for pertussis and for rabies vaccine. These include:
Operational approach
Purpose/scope
The purpose of the 3Rs working group is to assist DCVMN members in their decision-making process, in the development and implementation of novel methods for vaccine testing considering the 3Rs Principle. This includes the establishment and standardization of new test assays for existing vaccines and vaccines under research and development setting as a priority in the validation and implementation of methods complying with the 3Rs principles.
Objectives and Role
The working group objectives and role is presented in the table below.
Objective | Role of the 3Rs working group |
---|---|
Promotion of harmonized alternative methods. |
|
Enhanced expertise and implementation of novel testing methodologies. |
|
Implementation of 3Rs. |
|
Promote the acceptance by pharmacopoeias, NRAs of alternative testing methods aimed at reducing, replacing or refining the use of laboratory animals. |
|
Composition
A group of around 10 manufacturer participants is considered optimal for effective group functioning, including to the extent possible participants from all the main geographical regions and from both state and private companies, to ensure as wide as possible representation and input of views and experience. Others may be involved in specific regional initiatives, if these arise. All DCVMN members will be regularly updated through ad-hoc communications, webinars or reports. Each participant would need to dedicate a small percentage of his/her time to work in the group. Group structure will be informal but the nominated Chair and a co-chair are responsible for providing continuity to the discussions. DCVMN will arrange for a facilitator to help run the group meetings.
Membership and governance
Duties and responsibilities of members
Working Group members from DCVMN affiliated companies will act on a voluntary basis and need to declare any conflicts of interest they may have regarding any work undertaken.
Each participant will act on behalf of the respective corporate member and best contribute to the specific annual workplan. This will include reviewing specific topics being addressed and, if relevant, adding the perspective of the manufacturing company that they represent. Participants will be expected to discuss topics with colleagues to enhance the analyses undertaken. Participants whose situation changes and can no longer serve on the group will inform DCVMN secretariat to allow another participant to be identified.
Operations
A workplan will be agreed upon, including the specific topics to be covered with timelines and deliverables. The group will agree on key performance indicators (KPIs) to evaluate progress at regular intervals. Group meetings will largely take place through remote communication (telephone calls, WebEx, and email), but at least one face-to-face meeting should take place yearly. Meetings where at least half the WG members are coincidentally attending are good opportunities to hold a WG face to face meeting. Any group meeting (telephone, email or face-to-face) will have a set goal and agenda as well as required minimum quorum: half the participants plus one, ensuring decisions are taken in a collegial manner. Discussions will aim for consensus but also note any specific regional or manufacturer differences/preferences that may exist and will be respected.