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ONLINE TRAINING: Regulatory and Scientific Pathways for Global Advanced Therapy Medicinal Products Development (ATMPs)

A broad scientific and regulatory overview of the current status and challenges facing ATMPs development

Date

17-19-24 November 2020

Location

Online

Language

English

ONLINE TRAINING: Regulatory and Scientific Pathways for Global Advanced Therapy Medicinal Products Development (ATMPs)

Advanced therapy medicinal products (ATMPs) are currently undergoing a boom. Several products including viral, non-viral and cell-based products have forged a path to market. In their wake, academics and clinicians continue to lead innovation and unlock the clinical potential of new approaches and technologies, whereas increased industry interest is stimulating investment and industrialization of the processes that lead to commercialization. 

This online training course is designed to give a broad scientific and regulatory overview of the current state of the art and challenges facing ATMP development. It will follow the life cycle of an ATMP from concept to clinic and commercialization. and it will take into consideration global regulatory requirements and the often-challenging regulatory problems that ATMPs face.

MODULE 1 

1. Introduction to ATMPs and drug development

  • Overview of small molecule drug development vs complex biological drug development
  • EU regulatory framework for ATMPs
  • US regulatory framework for ATMPs

2. Getting on the right track: early stage regulatory procedures for ATMP development

  • ATMP classification
  • Early stage regulatory procedures brief overview Orphan drug designation (ODD), Paediatric investigation plans (PIPs) and Pediatric study plans (PSPs)., Innovation meetings / scientific advice / protocol assistance / pre-IND meetings, Risk-based assessment and PRIME


MODULE 2 

3. Chemistry, manufacturing and controls (CMC) for ATMPs

  • Introduction to GMP and GMP guidelines
  • Gene therapy manufacture main concepts
  • Cell-based therapy manufacture main concepts
  • QP release and import/export

4. Nonclinical issues

  • Overview of nonclinical studies and timing
  • Certification of CMC and/or nonclinical data for ATMPs and SMEs


MODULE 3 

5. Clinical issues

  • CTAs and IMPDs/IBs and INDs
  • GMO licenses
  • Clinical trial design considerations
  • Shedding studies

6. Marketing authorization procedures

  • Centralised procedure (EU) and Biologics license application (BLA) (USA)
  • Accelerated assessments, expedited pathways and conditional approval
  • Hospital exemption and compassionate use
  • Post-marketing commitments including PSUR and Risk management plans (RMPs)


Course Language

The online training will be in English

Núria Coderch
Núria Coderch Scientific and Regulatory Affairs Director, Asphalion S.L.

Núria has a PhD in Pharmacy.  She has an academic research career and a broad scientific background in the area of microbiology and pharmacy with over ten years’ experience as regulatory expert in charge of medical and scientific writing. As the director of the Scientific and Regulatory Affairs unit, Núria is a recognized expert in small molecules as well as innovative, biological and advanced therapy medicinal products (ATMPs), including gene and somatic cell therapies. She is also responsible for managing regulatory work packages of FP7 and H2020 projects and working in regulatory strategy and has vast experience in a range of global procedures including registration dossiers, IMPDs, IBs, CTAs, INDs, scientific advice, pre-INDs meetings and regulatory procedures during development.

Christopher Mann
Christopher Mann Scientific & Regulatory Affairs Associate Director, Asphalion S.L.

Christopher has a PhD in Biomedicine. Christopher had an academic research career in gene therapy including muscle regeneration and muscular dystrophy as well as using muscle as a platform for gene therapy applications including diabetes. He has over seven years’ experience as a regulatory expert in medical writing and scientific and regulatory affairs for chemical and biologic products, including advanced therapies, biomaterials and complex new technologies. He has experience in both EU and US regulatory affairs including scientific advice/pre-IND meetings, clinical trial documentation, paediatric assessments, and commercialization procedures. As Scientific and Regulatory Affairs Associate Director at Asphalion, Christopher is involved in regulatory strategy, regulatory roadmaps and support for startups and biotechs, qualification of novel methodologies for biologicals, biomaterials, and advanced therapies. He also manages and leads regulatory Work Packages for H2020 projects.

Marta Rayo Lunar
Marta Rayo Lunar Scientific & Regulatory Affairs Associate Director, Asphalion S.L.

Marta has a Pharmacy degree and a Specialist postgraduate degree qualification in Industrial Pharmacy and Galenic Formulation. She has over seven years’ experience in drug development in the pharma Industry as R&D Project Manager on the development of drug candidates, and over five years’ experience in regulatory affairs. As Scientific and Regulatory Affairs Associate Director at Asphalion, Marta is responsible of scientific and medical writing of regulatory documents working in regulatory strategy, regulatory roadmaps, ATMP designation, scientific advice and qualification of novel methodologies for biologicals, biomaterials, medical devices, and advanced therapies. She also manages regulatory Work Packages of H2020 projects.

  • Regulatory Affairs Manager, Officer and Specialist
  • Development Pharmacist
  • Project Manager

working for pharmaceutical company, Biotech, spin-offs and CROs. 

It is also addressed to Researchers and academics in the ATMP field


Participant experience

Participants need to have a basic understanding of regulatory procedures and/or a basic knowledge of ATMP biology.

This limited enrolment online training course is intended to be a virtual class where various expert will guide you into the topics through real world case studies and examples and answering your questions.

Online interactive training on Zoom platform. 

Online Training - 3 modules

November 17th, 2020             9:30 – 12:30 CEST

November 19th, 2020             9:30 – 12:30 CEST

November 24th, 2020             9:30 – 12:30 CEST


After the registration, you will receive all details about the connection.

The course admits maximum 12 attendees.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Certificate of attendance

Early Bird€ 1.100,00* (until 27 October 2020)

Ordinary€ 1.210,00*

Freelance - Academy - Public Administration**€ 660,00*


* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance - Academy - Public Administration fee

The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Register now

Course Price

1210.00 €

Early Bird

Tuesday, October 27, 2020

1100.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

3 modules (3 hours each)

Course Type

Limited number of participants

You will receive

Certificate of attendance

At the end of the training, you will be able to

  • Understand drug development pathways and pitfalls as they apply to ATMPs around the world

  • Identify possible obstacles and the available resources and solutions for dealing with them

Participants' Feedbacks

Good atmosphere in the group and interaction with the lecturers (really available for all questions)

Lecturers know what they are talking about and are able to answer the questions. It's clear that they work and have experience in the field

no standard workshop which is very stressful so the way that this course was conducted was excellent and the first one for me were I was so relaxed… thank you for that feeling!

International and multidisciplinary profile of participants, which enriches the training

Exemples from real life situations from the workplace were very useful.

Excellent interaction between teachers and participants

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ONLINE TRAINING: Regulatory and Scientific Pathways for Global Advanced Therapy Medicinal Products Development (ATMPs)

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Terms & Conditions

Trainings
The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Conferences
The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail: events@LSAcademy.com  telephone: +39 (0)35.515684

Webinars
The fee includes: tuition, teaching materials, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee. For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Common Terms & Conditions

Terms of payment
Payment should be made online (by credit card) or by bank transfer, at the time of registration (only for Italian companies: + 22% VAT) to EasyB s.r.l by bank transfer or by credit card. Bank transfer payable to:

EasyB S.r.l.
Via Roma, 20 – 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
BANCO BPM – Filiale di Carobbio degli Angeli
IBAN: IT81 F 05034 53960 000000003450
SWIFT Code: BAPPIT21AY5

Confirmation of event admission will be given on receipt of payment. Invoice will be sent following receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

Cancellation
Please note that refunds (50% refund of the registration fee) will only be given if cancellation is received at least four weeks before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed for free and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event, to change its performance from residential to webinar/online. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, hostilities, epidemics, pandemics, and / or authorities’restrictions (so-called factum principis).

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In accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, we inform you that EasyB S.r.l. (with headquarter in Via Roma 20, Alzano Lombardo, Bergamo, Italy, VAT number IT03633040161), as the data controller, will use your personal data voluntarily provided by you only with the consent and in compliance with the principles dictated by the European Regulations on the protection of personal data for, for the management of participation in the course, for sending the newsletter, and for dissemination purposes. You can read the complete information, including your rights and how to exercise them, following this link.