Special Interest Networks (SPINs)

Our Special Interest Networks (SPINs) support regulatory affairs professionals working in the same specialist sector by providing a dedicated forum for discussion and sharing knowledge and information.

The aim of the SPINs is to:

  • Provide forums for exchanging views and ideas and offer mutual support
  • Ensure that the needs of these sectors are included in the TOPRA training programme and encourage expert input into course content
  • Encourage contributions to Regulatory Rapporteur
  • Current SPINs


    Originally established in 1996 as the Biotech Working Party, the aim of the Biotechnology SPIN is to promote the development of realistic, common-sense and science-based approaches to the regulation of biological medicinal products by providing a sound understanding of the basic science and the available and emerging regulatory guidance via a focused education and training programme.

    Its membership is made up of those who are involved in the full spectrum of applications of biotechnology and biologicals within the biopharmaceutical industry (recombinant proteins including biosimilars & monoclonal antibodies, vaccines and advanced therapies), all disciplines of regulatory affairs for these products (CMC, preclinical and clinical and regulators) and all sizes of company.

    Current activities Biotechnology SPIN Steering group 
    • Organising several TOPRA courses, including Module 9 of the MSc in Regulatory Affairs
    • Providing input to the TOPRA Annual Symposium
    • Support and contributions to the publication of biotech-related articles in Regulatory Rapporteur
    • ABC Biological (introductory level biological / ATMP webinars)
    • Reg Rapp articles, May 2023
    • Member Webinars
    • Risk based approach to ATMPs
    • Current development in ATMPs-Quality
    • Clinical development of ATMPs
    • Symposium session 2023
    • Collaboration with other SPINS and MSc Modules

    We are looking to further expand our range by offering more frequent and informal opportunities to share and learn.

    Those who join this SPIN are encouraged to contribute and can draw on the knowledge of the network’s members. As the network is there to serve the members, you can influence the development and format of the network and become actively involved with the activities of the SPIN Steering Group.
     

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    The purpose of the Chemistry, Manufacturing and Controls (CMC) SPIN is to create a forum where TOPRA members working within Regulatory CMC functions across the globe, have an opportunity to share knowledge and experiences. 

    The SPIN steering group is made up of members with a range of backgrounds and experiences and covers a wide variety of drug modalities spanning small molecules, antisense oligonucleotides, synthetic peptides, proteins and ATMPs.  The aim of the steering group is to provide a forum, allowing for cross-company sharing and collaboration and facilitates this by arranging regular webinars covering hot topics in Regulatory CMC, discussing the latest guidance, experience or trends and providing education opportunities for the TOPRA membership.

    Any suggestions for topics for future webinars or expression of interest in becoming a steering group member are very welcome!


    CMC Committee members:
  • Steve Wood
  • Gabriel Bohl
  • Angela Currie
  • Olivier Dirat
  • Peter Blakeney 
  • Sarah Fitzgerald
  • Imke Veltman
  • Michal Mista
  • Anita Murray
  • Francisco Baptista
  • Julien Douillet
  • Marine Joly-Battaglini

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    The purpose of the Combination Products SPIN is to create a forum where TOPRA members working with combination products across the pharmaceutical world and the medical device world have an opportunity to share knowledge and experiences.

    The aim of this group is to organise monthly meetings that are a mixture of informal discussions, cases presented by the members, webinars presented by members, knowledge sharing from meetings, and presentations by guest speakers.

     

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    The aim of the clinical trial SPIN is to provide a forum for exchanging views, ideas, interpretation of new guidance and mutual support on regulatory aspects of global clinical trials. The membership of the CT-SPIN is made up of those with wide-ranging levels of experience who are involved in various aspects of regulatory support for clinical trials, from all sizes of companies, CRO’s and service providers.

    The aim of this group is to meet regularly (usually every one or two months) to:

  • Share updates and interpretation of new guidance, 
  • Knowledge share from subject matter experts who may be industry representatives for the development of CTIS / EU-CTR implementation experts
  • Provide question-and-answer sessions
  • Have informal discussions
  • Present case studies from CT-SPIN members
  • Receive presentations by guest speakers
  • Have joint discussion topics with other SPINs

  • All TOPRA members are most welcome to join the CT-SPIN. All CT-SPIN members are strongly encouraged to contribute to discussion topics around the regulatory aspects of clinical trials, share experiences (without disclosing company confidential information) and draw from the knowledge of the network’s members. You are also encouraged to suggest future discussion topics, present case studies, discuss emerging guidance, relevant hot topics and become actively involved with the contributions of the CT-SPIN Group to TOPRA’s publications, courses and events.

    It's members include:
  • Christine Grew (co-Chair)
  • Chris Price (co-Chair)

  • Activities

  • Discussion topics: EU-CTR, transitional trials, transparency requirements, CTIS ACT-EU, COMBINE, MHRA combined review CTIMP, IRAS, regulatory processes for CTAs in other countries, interplay of EU-CTR with MDR & IVDR, CTAs for ATMPs & GMOs
  • Develop expert CTIS user knowledge sub-group
  • Delivery of TOPRA webinar – Trials, Transition and Transparency 
  • Contribute to the Regulatory Rapporteur e.g.,: First experiences with the Clinical Trial Regulation – A company perspective - June 2023 
  • Collaborate with other SPINs e.g., join discussions with the CMC and Combination Product SPINs
  • Support TOPRA with courses and events e.g. Annual Symposium, Introduction to Regulatory Affairs, Clinical Trials Module
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    The aim of the MedTech SPIN is to exchange regulatory intelligence and experiences, particularly useful to those working in smaller companies.

    Its activities include:

  • Technical input to the MSc in Medical Technologies Regulatory Affairs
  • The production of one-day training courses on medical technology topics, including those which are part of the CRED programme 
  • Input on medical device topics to TOPRA’s Introductory Courses
  • Development of the Medical Devices programme of the TOPRA Symposium
  • Contribution to Regulatory Rapporteur
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    A SPIN Steering group has been formed of regulatory professionals.  It works to raise awareness of the value of regulatory affairs as a fulfilling career and to identify opportunities to collaborate across the sector.

    It's members:

  • Nicole Small
  • Sylvia Lobo
  • Ricky Radia
  • Aksa Rahman
  • Célia Cruz
  • Edmar Campos
  • Pavithra Saravanan
  • Figen Kabadas
  • Khatriny Sousa
  • Ashley Stratton-Powell

    It's achievements:
  • Delivered two Careers Live events in 2023
  • Delivered a number of lectures to student organisations and alumni
  • Published articles in Regulatory Rapporteur with focus on talent and professional development 
     
    It's priorities for 2024-2025:
  • Continually refresh and support the delivery of TOPRA Careers Live events to attract new talent into the profession and to develop an understanding of career opportunities within it.
  • Work in partnership with educational institutions, other professional societies and student societies to increase awareness and understanding of Regulatory Affairs as a profession.
  • Improve accessibility/navigation of information on TOPRA website, creating free sources where possible.
     
    Useful resources:
  • Careers in Regulatory Affairs (topra.org)
  • Stay in touch | TOPRA Connect newsletter (free monthly email newsletter)
    If you are interested in joining the NRP Steering group, contact jitesh.mistry@topra.org.
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    The Patient Engagement SPIN is intended to be a source of best practice for applying patient engagement insights and learnings in the drug and medical devices development lifecycle.

    The primary aims of the group are to:

  • To define a common understanding and definition of how Patient Engagement currently operates in the drug and medical devices development lifecycle and future opportunities for involvement across the life cycle
  • To provide a forum for members to share and build knowledge and ideas on ways to incorporate the patient voice early and consistently as a clinical program evolves
  • To promote the importance of patient engagement from a regulatory perspective
  •  

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    The Pharmacovigilance SPIN was established in January 2009 to provide a forum for regulatory affairs professionals working in the field of pharmacovigilance. 

    The primary aims of the group are:

  • Raise the awareness of global pharmacovigilance in a European context
  • Promote collaboration between individuals and with other organisations involved in drug safety
  • Contribute to the raising of professional competency, standards and understanding of pharmacovigilance
  • Provide a forum for the exchange of information/knowledge transfer
  • Provide insights in and raise awareness of future developments
  •  

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    The primary aims of the Product Information and Labelling SPIN are to:

  • Share regulatory knowledge and experiences related to product information across drug product life cycle
  • Provide training opportunities to less experienced members in the area of product information
  • Voice opinions via TOPRA to legislation consultations organized by regulatory agencies (EMA/MHRA/FDA)
  •  

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    The Regulatory Operations SPIN Steering Group provides a vendor neutral forum to share guidance, advice, ideas, best practice and news on all aspects of Reg Ops for professionals from the pharma, biopharma, cosmetics, device and veterinary sections.  

    The RO SPIN offers an opportunity to network and learn from each other, including collaboration with other SPIN groups within the wider TOPRA community.

    Mission statement

    Exchanging regulatory operations ideas, challenges and good practices via a vendor neutral and independent forum with a wide range of group members including pharma, biotech, and medical device, veterinary and consulting services industries, offering opportunities for personal development and growth. 

    Aims

    • To provide regulatory professionals a forum to promote the exchanging of views, ideas and good practices for individuals, small/medium enterprises, major corporations and regulators to share regulatory operations experiences.
    • To act as a vendor neutral and independent source of collective information without sharing any company sensitive or IP information or permitting software or service promotion.

    • Objectives

    • To share knowledge with members on the developments in the Regulatory Operations landscape in an open forum for discussion.
    • To host and/or collaborate with other SPIN groups on topics that are in the best interest of the SPIN/TOPRA community.
    • To encourage expert contributions to the Regulatory Rapporteur platform, including Podcasts and commentary pieces, on specialist topics of relevance for Regulatory Operations professionals.

    Steering Group Members


    Interested in joining the Regulatory Operations SPIN Steering Group?

    The RO SPIN Steering Group meet on a regular/agenda driven basis to discuss new intelligence within the Regulatory Operations environment, potential seminar/webinars as well as improvements for the wider SPIN community. 

    If interested, please contact membership@topra.org to get involved.

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    The Regulatory Intelligence SPIN was established to provide a forum for members to share and build knowledge and ideas on Regulatory Intelligence, i.e. the act of collecting, analysing and using regulatory data from multiple sources to gain successful outcomes. This includes landscape of the current and evolving regulatory environment for opportunities and challenges to shape future guidance, regulations, legislation and policy.

    The primary aims of the group are to:

  • To organise meetings, webinars and opportunities for the RI SPIN group.
  • To seek opportunities to collaborate with other SPINs for webinars, knowledge-sharing and to feedback on regulatory changes and interpretations.
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    The purpose of the Digital health SPIN is to create a forum where TOPRA members working with digital health (including medical device software and artificial intelligence), or those interested in the topic have an opportunity to share knowledge and experiences.

    The aim of this group is to organize quarterly webinars that are a mixture of webinars by invited guest speakers or members as well as informal discussions, and knowledge sharing.

    Details of frequency of meetings of the committee: Quarterly

    Agenda topics discussed at meetings: Medical Device Software, Artificial Intelligence, Software Device Lifecycle, Cybersecurity, Health Data, Interoperability

    SaMD Committee members:

  • Célia Cruz
  • Angelina Munabi
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    The Veterinary SPIN was established to provide a forum for TOPRA members involved in the veterinary / animal health field to exchange of information, discuss topics of mutual interest and share of experiences.

    A small working group drawn from this SPIN is involved in the development and running of of the Veterinary Medicines programme of the TOPRA Symposium.

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    Upcoming SPIN events

    Start dateTitleDescription
    31/10/2024Biotech SPIN Webinar: Risk Based Approach To ATMPsFollowing on from the successful series of webinars on ATMPs in 2021, Dr Bridget Heelan returns with an updated presentation on the risk based approach to ATMPs.BIOOCT24

    Get involved

    To find out more about how to get involved with our SPINs, please email our membership team.