HMA Substances Validation Group

The HMA Substances Validation Group (SVG) has the following tasks:

 

  1. On behalf of HMA, maintain substances data in the European Substance Registration System (EU-SRS), containing scientific substance information.
    • Analyse the available substances data, available in regulatory documentation as well as in public databases such as G-SRS or Scifinder.
    • Register, validate and approve substances data
    • Update substances data when new information is available
    • Ensure ISO IDMP compliance of data
    • Provide feedback to the EMA SMS team in case of necessary changes on substances data in SMS
  2. Maintain and publish substances management guidance documentation
     
  3. Maintain training materials for NCA (read-only) users of EU-SRS, and publish in the HMA – SVG site along with the guides
     
  4. Support NCA’s and NCA staff with using EU-SRS and extracting data from EU-SRS, either by releasing learning materials or direct support
     
  5. Liaise with HMA as well as other expert groups / `regulatory´ groups, associations from interested parties or stakeholders, including but not limited to:
    • EMA SMS team
    • FDA/NCATS team
    • HMA working groups such as CMDh, CMDv, HMPWG
    • EDQM
    • European Commission
    • EMA’s committees and working parties such as CHMP, CVMP, HMPC, BWP, QWP
    • IWP (immunologicals working party)
    • NCA EU-SRS users
    • Kew Gardens
    • WHO
  6. Current three SVG groups are implemented as corresponding `sub-working groups´ (covering both Human and Veterinary substances):
    • SVG1, covering Chemicals, Polymers, Mixtures, SSG1
    • SVG2, covering Proteins, ATMPs, Nucleic Acids, Vaccines, Blood Products
    • SVG3, covering Homoeopathics and Herbals
  • Substance experts from AT, CZ, DE-PEI, DE-BfArM, DK, ES, FI, FR-ANSES, FR-ASNM, NL, and NO are part of different groups
  • Representatives from other agencies new and previous participants,  are welcome to join in the groups.
  • The group includes guest membership of WHO-UMC (no access to EU-SRS).
  • Chair: Marcel Hoefnagel, CBG-MEB, NL
  • Vice-chair: Bjørg Overby, NoMA, NO
  • Mentor: Trygve Ottersen, NoMA, NO
  • Secretary: Isabel Lazaro, AEMPS, ES
  • Meeting cycle: one two-days face-to-face meeting, one two-half day online per year. Regular teleconference meetings, including bi-weekly status meetings technical meetings, and SVG1, SVG2 and SVG3 group meetings.

SVG secretary

E-mail: svgnoSpam@noSpamhmanoSpam.eu

 

General documents
 

Newsletter
 

 

Call for Expression of Interest for SVG Secretariat

SRS is a substance database that went live in January 2023 and is available to the NCA’s since 2024. EU-SRS is sustained by the HMA SVG (Substance Validation Group). The SVG has been supported by a secretariat since 2024. A new secretariat officer is sought. The estimated required FTE is 0.3-0.4.

The tasks and competencies required are listed below.

Identified tasks of SVG Secretariat:
 

  • Organizing and hosting meetings:
  • Regular team meetings
  • Bi-annual f2f meetings (agenda, logistics, minutes)
  • Transatlantic alignment meetings
  • Collecting EU-SRS improvement proposals
  • Gather feedback from SVG members
  • Analyse the feedback together with technical team
  • Prioritization of improvement proposals with the team
  • Liaise with developers team how to implement the proposals
  • Maintain SVG-SRS mailbox, when available
  • Allocate questions/requests to the relevant SVG groups
  • Liaise with NCA’s on EU-SRS matters
  • Maintain the HMA SVG Working group website
  • Publish updated substances guides on HMA SVG internet page
  • Publish updated content as well as news items
  • Maintain annual roadmap for EU-SRS/SVG
  • Stakeholder management
  • Reach out to stakeholders to align on substances matters
  • EDQM, FDA/NCATS, Kew Gardens, EMA, SMS, ISO
  • Support in software testing, if needed

SVG Secretariat – competency profile:
 

  • Excellent communication skills (English)
  • In writing and verbal
  • Presentation skills
  • Organizational sensitivity
  • Excellent organizational skills
  • Higher education (e.g. bachelor, university or similar degree)
  • Able to work with Ms Office (Excel, PowerPoint, SharePoint)

Skills to be learned on-the-job, if not yet available:
 

  • Basic understanding of ISO-IDMP, or affinity with standardization topics
  • Basic understanding of relevant databases
  • SPOR, including SMS
  • GSRS in relation to EU-SRS
  • EU-SRS: use of CV’s, User rights, database validation rules