Good Manufacturing Practices

GMP OF BIOLOGICAL PRODUCTS
AND INNOVATIVE THERAPY MEDICINES

BPF11

Date

March 15 2018

7 h face-to-face

Effective work

Formative

Laurent LAGANIER

Price

800 € HT

(Déjeuner inclus)

Objectives

- Understand new regulatory requirements for organic products for GMP for France, EU and WHO.
- Review and understand the latest decrees, regulations and recent proposals for Good Manufacturing Practices for Innovative Therapy Drugs (MTI)

Public

  • Beginner
  • Intermediate
  • Expert

- Pharmaceutical industry and associated industries producing organic products, Establishment MTI or MTI PP
- Biotechnology: production, quality control, quality assurance, technical departments, logistics and
Regulatory Affairs

Programs

This training is based on the presentation, understanding and application of the latest GMP regulatory standards applicable to biological and biotechnological products. It includes the review of Annex 2 2014 and BPDG 2014 as well as those of WHO for BPDs and heat-sensitive products. The specificities of therapy drugs are reviewed and discussed with regard to their GMP and specific regulations.

EU Annex 2 2012

  • Background: European legislation, why a new 2 Annex, scope
  • Presentation: common part, specific part for different categories of biological and biotechnological products
  • Conclusion: main novelties and possible future changes


Innovative therapy drugs

  • Context: the opposable regulation and its probable evolutions in GMP / GMP
  • Presentation: the different types of MTI and MTI Prepared Punctually (MTI-PP), the hospital exemption, changes and difficulties encountered


Medicinal products

  • Regulatory requirements production
  • Specificity of setting up an MTI OGM clinical trial

Assessment of acquired knowledge and evaluation of improvement actions undertaken and / or envisaged
Questionnaire de satisfaction

Program PDF version

To download the program of this training in PDF format, please click on the button below.

Cette journée s’inscrit dans le cadre de la formation professionnelle.
N° Déclaration : 82 69 13448 69 Préf. Région Rhône-Alpes
SARL au capital de 10 000 Euros Siret 451 934 541 00025
* Average score given by previous trainees

Laganier

Laurent LAGANIER - APHP

Currently, person in charge of the Medicines of Innovative Therapy and quality manager within the Unit of Cell Therapy and Genetics of the Necker Hospital (APHP), he was responsible R & D, pharmacist responsible and control manager of TBF, which also produced Innovative Therapy Drugs.

Educational medium

At the beginning of the session, through a questionnaire, the trainer analyzes the level of knowledge of the professionals on the subject as well as their expectations of the knowledge to be acquired. The trainer adapts the training program according to the profile of the different participants. Time is spent exchanging experiences between participants and with the trainer.

Pour un bon suivi du stage, le stagiaire dispose d’un ou plusieurs supports de cours en version numérique et en version papier.

Concrete cases in working groups to help the participants to apprehend on their site the implementation of the new version.

Referencing the DataDock

Single database that refers to training organizations that meet the criteria established by the funders.
Evidence of the proper application by the structures of the criteria set by the quality decree. The latter specifies how the training funders (OPCA) must ensure the capacity of the training organizations to provide quality training actions.

This referencing certifies the quality of our training according to 6 criteria and 21 indicators defined at national level by the funders.
Guarantees :
- The precise identification of the objectives of the training and its adaptation to the trained public.
- Adaptation of the reception, pedagogical monitoring and evaluation systems to trainee audiences.
- Adequacy of pedagogical, technical and supervisory resources to the training offer.
- The professional qualification and the in-service training of the staff responsible for training.
- The conditions for informing the public about the training offer, its access times and the results obtained.
- Taking into account the assessments made by trainees.

To register for this training, please return the registration form.

All our courses take place at 30 rue Pré-Gaudry in Lyon 7ème and start at 8h30 and end between 17h and 18h.

Contact

According to your requirements and your preferences, you can contact Marion Provini:

Phone: +33 (0)4 37 28 30 49
Fax: +33 (0)4 37 28 30 60
E-mail : mprovini@a3pservices.com
Mail: A3P Training, 30 rue Pré-Gaudry - Lyon 69007
On site: 30 rue Pré-Gaudry, Lyon, from Monday to Friday

Accessibility

50

Hotels nearby

Hotels **

Séjours & Affaires Hotel - Park Avenue
2 rue Madeleine Fourcade, 69007 Lyon - Tel: + 33 (0) 4 37 65 59 59
5 min walk
Offer Training A3P

Appart City Lyon - Part Dieu Villette
6 Avenue Lacassagne, 69003 Lyon - Tel: + 33 (0) 4 37 91 99 21
4 metro stops (Part Dieu)

Hotel Séjours & Affaires - Saint Nicolas
90 Boulevard Vivier Merle, 69003 Lyon - Tel: + 33 (0) 4 37 48 24 24
4 metro stops (Part Dieu)
Offer Training A3P

Hotel Séjours & Affaires - Saxony Gambetta
34 Great Street of the Guillotière, 69007 Lyon - Tel: + 33 (0) 4 72 71 91 92
2 metro stops (Saxe Gambetta)
Offer Training A3P

Hotels ***

Park And Suites Lyon Gerland
175 avenue Jean Jaurès, Lyon 69007 - Tel: + 33 (0) 4 37 37 25 25
5 min walk

Mercure Lyon Beaux Arts Centre
73-75 rue du Président Edouard Herriot, Lyon 69002 - Tel: + 33 (0) 4 78 38 09 50
30 2 min (2 different subway lines)

Hotels ****

Novotel Gerland
70 avenue Leclerc, 69007 Lyon - Tel (+ 33) 4 72 71 11 11
20 min walk

Quality Suites Lyon 7
Felix Brown Street 7, 69007 Lyon - Tel: + 33 (0) 4 37 37 23 70
3 min walk

Novotel La Part Dieu
47 boulevard Vivier Merle, Lyon 69003 - Tel: + 33 (0) 4 72 13 51 51
15 minutes by car
4 subway stops

Mercure Lyon Part Dieu
50 rue de la Villette, 69003 Lyon - Tel: + 33 (0) 4 72 68 25 20
15 minutes by car
4 subway stops

Novotel Confluence
3 St. Paul Montrochet, 69002 Lyon - Tel: + 33 (0) 4 37 23 64 00
30 min tram and bus