Discover the course

ONLINE TRAINING: Advanced FDA Regulatory Affairs

In-depth review of US Regulatory Affairs environment

Date

4-5 November 2020

Location

Online

Language

English

ONLINE TRAINING: Advanced FDA Regulatory Affairs

For anyone interested in developing for and registering products in USA, this online training course will give all the required information about how to set-up your product development and successfully achieve registration with FDA.

Module 1

Advanced FDA Communications 

a) Current Hot topic

  • Impact of covid-19
  • Update on the programs FDA is working on: cooperation program with other countries for drug approval Project Orbis

b) Formal meetings with FDA

  • Scope of meetings
  • Meeting types
  • Meeting formats
  • Type B meetings
  • Meeting Request
  • Meeting package
  • FDA preliminary responses
  • How are meetings conducted


FDA Application type and dossier requirements 

a) IND

b) New Drug Application: NDA, Art. 505 (b)(2), BLA

c) US generic products – the ANDA pathway


Module 2 

FDA programs for Accelerated Development

Expedited pathways – Go Faster!

a) Go faster! Breakthrough Therapy, Fast track, Accelerated Approval and Priority Review

b) Overview of FDA incentives: vouchers, waivers and designations

c) Hot topics: How FDA managed drug-development during covid-19 outbreak?


Advanced regulatory affairs for Drug Development in the US 

Orphan Drug Designation (ODD)

a) US ODD requirements

b) Comparison EU vs. US


DMF registration



Course Language

The online training will be in English

Lidia Canovas
Lidia Canovas Director of Regulatory Affairs at Asphalion S.L.

Lidia has a Pharmacy and MBA degree.
She has more than fifteen years overall experience in pharmaceutical industry, most of which as Regulatory Affairs Director, but she has also covered the role of Vice-Director for Research and Development. She has worked at Asphalion for ten years as General Manager and Director of Regulatory Affairs. In this second role, Lidia is responsible for the overall quality of the Regulatory and Scientific services that Asphalion provides to a large number of international and national clients.

Bruce Thompson
Bruce Thompson Principal at Reguliance

Bruce is an independent consultant with over 20 years’ experience in the pharmaceutical and biotech industries, possessing practical skills in the details of product development planning, regulatory strategy, and project management. He is Principal of Reguliance, which he founded in 2002. He has previous experience in the pharmaceutical industry as Managing Director, Director of Regulatory Affairs and Acting Director for US Regulatory Affairs for several companies for 10 years. He is member of the American Society of Gene & Cell Therapy (ASGCT), the Licensing Executives Society (LES) and the Regulatory Affairs Professionals Society – RAPS (certified 1994).


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

working for pharmaceutical company and CROs whit specific interest in FDA regulation.


Participant experience

Basic regulatory knowledge would be preferred

Theorical explanation of US regulatory framework for drug development, practical tips and tricks for communications with FDA and examples on how to develop and register your product with FDA, including parallel development to EU.

Online interactive training

Online Training - 2 modules

November 4th, 2020             2:00 pm – 6:00 pm CEST

November 5th, 2020             2:00 pm – 6:00 pm CEST


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

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€ 890,00* (until 21 October 2020)

Ordinary€ 1.100,00*

Freelance - Academy - Public Administration**€ 540,00*


* 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

1100.00 €

Early Bird

Wednesday, October 21, 2020

890.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

2 modules (4 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 communication programs with FDA during development

  • Have a clear overview of FDA accelerated programs

  • Be able to identify the main differences between EU and US in drug development

Participants' Feedbacks

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

Excellent interaction between teachers and participants

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!

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

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ONLINE TRAINING: Advanced FDA Regulatory Affairs

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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).

Information collection and use
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.