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Pharmacovigilance Working Group

Background

The DCVMN Initiative 6 refers to the increase and strengthening of pharmacovigilance (PV) capacities of DCVMN member companies to enable a stable and sustainable supply of quality vaccines in developing countries and to enhance vaccine safety monitoring to enable companies to implement a high standard mature “fit for purpose” PV System using best practices to comply with international and supranational expectations, as applicable.

Purpose

The purpose of the vaccine pharmacovigilance working group is to identify the needs for strengthening and improving pharmacovigilance systems for vaccine manufacturers in emerging countries so that DCVMN member companies are equipped with up-to date knowledge to implement best practices and formal training according to state-of-the art pharmacovigilance, aligned with WHO and relevant national regulatory requirements.

Objectives

The objective of the PV working group is the identification of the needs to improve and strengthen PV, the compilation and endorsement of relevant best practice material that inform DCVMN members on how to improve global vaccine safety monitoring, operational pharmacovigilance capabilities and proactively identify and respond to potential safety issues, including resource implications.

Authority

Group participants from DCVMN members act on a voluntary basis and need to declare any conflicts of interest they may have regarding any work undertaken. The DCVMN Executive Board will have the authority of determining the usefulness of any work undertaken and approving its dissemination.

Composition

A group of around 10 participants from member companies is considered optimal for effective group functioning, including to the extent possible, participants from all the main regions (Africa, Asia, Latin America) and from both state and private companies, to ensure a wide as possible representation and input of views and experience. Group structure will be informal with a Chair and Co-Chair nominated by the designated working group members. DCVMN may opt to arrange for a facilitator to help run the group meetings, if needed.

Criteria for participation in the expert group

Participants should be formal employees of a DCVMN member company and actively engaged in Pharmacovigilance. Participants must be qualified and have at least 2 years of experience in pharmacovigilance. Others may be involved in specific regional initiatives, if these arise. Each participant would need to dedicate a small percentage of his/her time to work in the group.

Duties and responsibilities

Each participant will act in representing the corporate member and best contribute to the specific agenda. This will include reviewing specific topics being addressed and, if relevant, adding specific analysis of the country situation in which the manufacturer is located. Participants will be expected to discuss topics with colleagues to enhance the breadth of analyses undertaken. Participants whose employment situation changes and can no longer serve on the group will inform DCVMN to allow another participant to be identified. The nominated Chair and Co-Chair will be responsible, in collaboration with the facilitator, for drafting the WG workplan, preparing the agenda, chairing meetings or teleconferences and providing guidance and continuity to the discussions, ensuring decisions are taken in a collegial manner.

Operations

A specific work plan will be agreed upon, including the specific topics to be covered with timelines and deliverables. Group meetings will largely take place through remote communication (telephone calls, WebEx, and email), but also face-to-face meetings during meetings where the Chair and at least half the participants are attending. Any group meeting (telephone, email or face-to-face) will have a specific set of topics for discussion and a required minimum quorum (Chair plus half the participants) ensuring a collaborative and balanced approach. Discussions will aim for consensus but also note any specific regional or manufacturer set-up differences may exist and be respected. Minutes of the group meetings (i.e., face to face meetings, telephone calls, Webex, etc.) will be taken for records and sent to all WG members within one week following the meeting.

Pharmacovigilance Working Group List of participants (as of 26th January 2022)

Name SurnameCompanyCountry
L. Nesbit – ChairBiovacSouth Africa
V. Indriani – CochairBio FarmaIndonesia
P. TakeyBio-Manguinhos FiocruzBrazil
L. ZhangCNBGChina
C. BhamareSerum Institute of India, LtdIndia
P. HonghoaVabiotechVietnam
H. XieBravovaxChina
Dr. YuvrajBharat BiotechIndia
M. LucchesiInstituto ButantanBrazil
R. KasiZydus Lifesciences LimitedIndia
K. HartmannExpert ConsultantSwitzerland
V. SharmaPATH ExpertUSA

  • November 18, 2022
  • June 6-7, 2022
  • April 29, 2022
  • February 25, 2022
  • December 8, 2021
  • May 20, 2021
  • April 6, 2021
  • March 2, 2021
  • February 2, 2021
  • December 16, 2020
  • November 12, 2020
  • September 9, 2020
  • December 1, 2019

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Risk Management Planning – Regulatory & Pharmacovigilance joint project 

Encouraged by inspiring discussions and achievements of 2020, such as the CRP implementation, the DCVMN Best Practice Working Groups on Regulatory and Pharmacovigilance shaped a joint project aimed at assisting manufacturers in learning how to prepare a robust Risk Management Plan (RMP) for a vaccine of their choice, for which they wish to achieve registration and WHO prequalification. The objective of this project is to strengthen the knowledge and capabilities of vaccine manufacturers in developing risk management plans to be submitted in parallel with Common Technical Dossiers, in order to meet the ICH E2E and EMA GVP Module V requirements.[15] RMPs are a regulatory requirement and are particularly important in the case of novel vaccines (targeting new diseases or produced using novel production platforms) with no or limited post-marketing data, such as the COVID-19 vaccines. 

The project was launched in May 2021, focusing on and limited to the development of a RMP for the monitoring of safety and effectiveness of any vaccine. The project involved an active learning process (learn-by-doing), whereby learners engaged in a series of five Q&A workshops: analysis, development, revision, synthesis, and evaluation of their own plans. Eleven member companies expressed interest, ten voluntarily engaged in the Q&A workshop series with senior expert professionals, and nine RMPs were drafted and reviewed by the experts for comments on improvements, while respecting confidentiality. This project enabled DCVMN member companies to voluntarily established a multidisciplinary team for risk management (safety and efficacy of vaccines) to draft a RMP that met, in principle, international standards.