aca24@aca-pharma.de/ +49 341 223 292 36

ACA CAMPUS

Your place for study, education and professional development

Over the past few years, we have been hosting seminars to train industry professionals, quality management and regulatory specialists, official bodies and consultants. Our seminars cover a wide array of topics related to pharmaceuticals, chemicals and biocides, including regulatory issues, where carefully selected professionals, industry experts and members of authorities pass on their knowledge to participants, give updates on the selected topics and answer all your questions.

Our seminars also aid students of the post graduate study course ‘Toxicology and Environment’, a study course run by the University of Leipzig. This post graduate study course offers academics to gain a wide spectrum of toxicological and eco-toxicological expertise and knowledge over a 5 semesters period. Students of this course will qualify as ‘Expert of Toxicology’ – the title that you can add to your existing professional title upon a successful completion of this course.

We invite industry experts, regulatory and quality management professionals, consultants, authorities and members of the post graduate course to take part in our seminars to deepen their knowledge obtained through work experience or during study.

Our ACA CAMPUS seminars at a glance:

 

Events Date Costs

Medicinal Products
Environmental risk assessment (ERA) of medicinal products for human use (Online Seminar)

This online seminar provides introductory and comparative insights in the ERA of human medicinal products (non-GMOs) based on the regularoty requirements according to EMA and FDA. With focus on the revised EMA Guideline the preparation of an ERA is explained more detailed.

 (Individual) Inhouse Online Seminar upon request

Online Seminar “Environmental risk assessment of medicinal products for human use” according to revised EMA guideline (EMEA/CHMP/SWP/4447/00 Rev. 1) coming in force in September 2024

Our online seminar explains the numerous changes and extended requirements resulting from the revision of the EMEA/CHMP/SWP/4447/00 guideline. This online seminar is divided into two modules and is practice-orientated. The focus is on the creation of ERAs based on the revised guideline with its many new features.

Module 1: Legal framework, data analysis and introduction to environmental risk assessment

Module 2: Phase II review strategy and extended environmental risk assessment

Seminar language: German

 tba from EUR 530.00
Evaluation & qualification of impurities in small molecule drug substances and products, cleaning validation, leachables and extractables (E&L) upon request

Medical Devices
“Medizinprodukte” (1-Tages-Online-Seminar)

Eine Verantstaltung mit aktuellen Beiträgen von Experten aus Behörden und Industrie zu verschiedenen Aspekten der MDR.

 upon request
“Medizinprodukte” (Online Seminars)

13 Online Seminars with focus on the medical devices regulation (MDR).

 from 185.00 €

Biocidal products & treated articles
Biozidprodukte – aktuelle Entwicklungen (Online Workshop)
 tbd
IUCLID6 for Biocidal Products upon request
IUCLID 6 BPR – Dossiererstellung Wirkstoffgenehmigung & Biozidproduktzulassung upon request

Product safety, REACH, CLP & national regulations

Product Notification according to CLP regulation

Formulators and importers of mixtures that are classified as hazardous have to submit a mixture notification (‘Poison Centre Notification’) via ECHA’s PCN portal – regardless of the tonnage. In our seminar you will be able to prepare your PCN and upload it to ECHA’s PCN Portal.

  

Individual Inhouse Online Seminar

 upon request

IUCLID 6 – Basis

Introduction to the current version of the IUCLID software tool and preparation of an Inquiry Dossier according to article 26, REACH, and a Registration Dossier for a Member of a Joint Submission.

  

Individual Inhouse Online Seminar

 upon request

IUCLID 6 for LEADs

Introduction to the current version of the IUCLID software tool and requirements for the preparation of a valid LEAD dossier in accordance with REACH. Information on data sharing and preparion of Letter of Access (LoA).

 

  

Individual Inhouse Online Seminar

 upon request

Statistical methods
Statistische Methoden in Medizin und Biowissenschaften upon request

Contact
Bianca Leubner
phone: +49 (0) 341-223 292 36
E-Mail: ACA_Campus@aca-pharma.eu

Comments are closed.