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
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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.
Join the conversation
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
Join the conversation
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)
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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)
Join the conversation
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.
Join the conversation
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.
Join the conversation