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.
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Chair: Francisco Baptista
Co-Chairs: Janine Jamieson and Lisa Hinchcliffe
Mission statement
The Chemistry, Manufacturing, and Controls (CMC) SPIN Group was established to provide guidance, advice, innovative ideas, updates, and a platform for sharing knowledge and experiences on all aspects of the CMC field, ensuring that our activities align with the best interests of the SPIN/TOPRA community.
The SPIN steering group consists of TOPRA members from around the globe, working within Regulatory CMC functions. These members bring diverse backgrounds and expertise, representing a wide variety of drug modalities and stages of the drug lifecycle—from early development to post-authorization. Our members come from pharmaceutical companies, regulatory authorities, and service providers, reflecting the diversity of CMC experiences.
The CMC Steering Group meets monthly on a structured, agenda-driven basis to discuss regulatory topics, share experiences (without disclosing company confidential information), address emerging hot topics, and review new guidance. Drawing from the extensive knowledge within the network, the group actively contributes to TOPRA’s initiatives, including publications, webinars, courses, case studies, and events.
Aims:
The SPIN group aims to:
Provide a collaborative forum to promote cross-company sharing and collaboration by exchanging questions, ideas, experiences, and best practices for TOPRA members.
Share regulatory CMC knowledge and experience throughout the drug product lifecycle via articles (e.g., Regulatory Rapporteur), webinars with CMC experts, and other educational content.
Facilitate informal discussions within the Steering Committee to foster collaboration and innovation.
Offer training opportunities for less experienced TOPRA members to develop their regulatory expertise.
Discuss and interpret the latest guidance, trends, and updates on CMC-related regulatory aspects, providing mutual support for navigating new regulations.
Monitor the evolving regulatory landscape to identify hot topics, opportunities and challenges, helping shape future guidance, regulations, and policies.
Collaborate with other SPIN groups to host joint webinars, share knowledge, and provide feedback on regulatory changes.
Advocate on behalf of TOPRA members by voicing opinions during public consultations by regulatory agencies such as EMA, MHRA, and FDA.
Current activities:
The CMC SPIN Group actively engages in a variety of initiatives to support TOPRA members and the broader regulatory community. These include:
Publishing CMC-Related Articles: Contributing to the Regulatory Rapporteur with in-depth articles on key topics, such as the October 2024 edition.
Hosting Webinars: Delivering TOPRA webinars on CMC-related topics featuring industry experts and emerging trends.
Cross-SPIN Collaboration: Partnering with other SPIN Groups, such as the Clinical Trials and Combination Product SPIN Group, to facilitate joint discussions and knowledge sharing.
Supporting TOPRA Activities: Collaborating on CREDs courses, MSc modules, and the annual TOPRA Symposium to enhance educational offerings.
Partnering with Other CMC Organizations: Building relationships and sharing expertise with external CMC-focused organizations.
Ongoing Topic Discussions: Exploring a wide range of current and evolving CMC topics, from Development to Post-approval.
Through these activities, the CMC SPIN Group provides a robust plan of activities for education, collaboration, and innovation in the regulatory CMC field.
Interested in joining the Chemistry, Manufacturing and Controls (CMC) SPIN Steering Group? Please contact
gloria.dwyer@topra.org to get involved.
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Chair: Stina Johansen
Co-Chair: Ming Ewe
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.
Interested in joining the Combination Products (CP) SPIN Steering Group? Please contact gloria.dwyer@topra.org to get involved.
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Co-Chairs: Christine Grew and Chris Price
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.
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
Interested in joining the Clinical Trials (CT) SPIN Steering Group? Please contact gloria.dwyer@topra.org to get involved.
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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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Co-Chairs: Silvia Lobo and Aska Rahman
Mission statement
This is a diverse group of regulatory professionals with a range of experiences focused on identifying, generating and supporting resources that promote Regulatory Affairs (RA) to people thinking of joining and support those new to this profession.
This SPIN group aims to
Raise awareness of regulatory affairs and its diverse opportunities for a fulfilling career.
Education through a robust plan of activities: guidance, advice, innovative ideas, updates, and a platform for sharing career knowledge and experiences, ensuring that our activities meet the needs of its community and the challenges it faces.
Identify opportunities to develop resources to support career awareness and development in collaboration with other SPIN groups.
Actively contributes to TOPRA’s initiatives, including Careers Live, webinars, courses and digital content.
The NRP Steering Group meets quarterly to discuss regulatory and recruitment topics, emerging themes and to identify digital solutions which are progressed through sub-teams.
Current activities
The NRP SPIN Steering Group actively engages in a variety of initiatives to support TOPRA members and the broader regulatory community. These include:
Continually refresh and support the delivery of TOPRA Regulatory Careers Live events to attract new talent into the profession and to develop an understanding of career opportunities within it.
Deliver lectures to student organisations and alumni and partner with educational institutions, other professional societies and student societies to increase awareness and understanding of Regulatory Affairs as a profession.
Communicate directly with potential and new professionals providing relevant support and signposting.
Publish relevant, contemporary content (in the TOPRA app and Career Progression webpage to meet current and future needs with a focus on collaborating with wider SPIN groups.
Improve accessibility/navigation of information on TOPRA website, creating a suite of free resources where possible.
If you are you interested in joining the NRP SPIN Steering Group and committing your time and ideas to support delivery of its activities then please contact Gloria Dwyer at gloria.dwyer@topra.org. Otherwise, please follow the work of the group in the NRP SPIN community in the TOPRA app where the group welcomes posts, ideas, comments and information from all.
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 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
gloria.dwyer@topra.org to
get involved.
Join the conversation
Chair: Pooja Thakur
Mission statement
The primary aims of the group are to:
To create a forum where TOPRA members working within Regulatory Intelligence functions across the globe, have an opportunity to share knowledge experiences and learn.
To seek opportunities to collaborate with other SPINs for webinars, knowledge-sharing to discuss on evolving regulatory landscape and its interpretations.
Aims:
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.
Achievements:
Every month RI SPIN meetings for relevant discussions and knowledge sessions on critical topics to have learning from each other’s experience.
Delivered the below knowledge sessions in 2024:
Managing Regulatory Intelligence for Global Markets by Pooja Thakur
Regulatory intelligence for PV by AYSHA Blagolash
EU Regulation 2024/1860 amending the EU MDR & IVDR by Ed Ball
International Regulatory Hot Topics by Janine Jamieson
Interested in joining the Regulatory Intelligence SPIN Steering Group? Please contact
gloria.dwyer@topra.org to get involved.
Co-Chairs: Angelina Munabi and Célia Cruz
The SaMD and Digital Health SPIN group aims to create a platform for addressing the regulatory challenges associated with SaMD and digital health sectors.
The group is dedicated to fostering knowledge-sharing and problem-solving among professionals in these sectors.
The aim of this group is to organize regular sessions that include a mixture of webinars by invited guest speakers or members as well as informal discussions.
Topics include regulatory updates and challenges around SaMD, AIaMD and Digital Health, such as software lifecycle, cybersecurity, software- and AI-related risks, sBOM, and new and developing guidance documents.
Interested in joining the SaMD & Digital Health SPIN Steering Group? Please contact gloria.dwyer@topra.org to get involved.
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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