Quality Risk Management (QRM)

Werk je reeds in een GMP omgeving, dan kom je al snel in contact met Quality Risk Management (QRM). In de training "Quality Risk Management (QRM)" kom je te weten wat de wettelijke vereisten zijn rond QRM en word je wegwijs gemaakt in het uitvoeren van een risico analyse door middel van de FMEA methode. Ook deze training is interactief zodat je de techniek meteen in de vingers krijgt.

Expert Session | 13 November 2019

8 Nov 2019

Start2FARMA: Contaminatie controle in Cleanrooms 2: Aseptisch werken in Grade A/B condities

Aanvullende dag volgend op CONTAMINATIE Controle 1

6 Nov 2019

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7 Nov 2019

Start2FARMA: CONTAMINATIE Controle in Cleanrooms 1: Algemeen en werken in Grade C/D-condities

Voor nieuwkomers in de industrie, geeft deze opleiding een bewustwording en goed begrip van het belang van een goede hygiëne en het dragen van de juiste kledij in geconditioneerde ruimtes.
Deze cursus biedt een fundamentele en technische achtergrond in hoe contaminatie kan vermeden worden in de productie van geneesmiddelen of medical devices. We zullen ook de regelgeving(en) en de huidige verwachtingen bespreken die dit onderwerp aanpakken.

1 Nov 2019

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13 Dec 2019

FINANCE for GROWTH

Are you an entrepreneur seeking investments and aiming for clear and convincing investment propositions? Or are you a Tech Transfer Officer, a Business Analyst or a Policy Maker or Advisor who needs to thoroughly evaluate business proposals and business cases? Then, gain insights in valuating and financing Life Sciences & Health SMEs through this course Financing for Growth, organised by Vrije Universiteit Amsterdam.

24 Oct 2019

Training Aseptische Technieken

De training “Aseptische Technieken” bestaat uit een theoretische training die dieper ingaat op het belang om contaminatie te vermijden in cleanrooms. Aangevuld met een halve dag praktijk in een cleanroom waar aspecten van omkleed procedure en het werken onder een laminaire airflow en de risico’s die daarmee gepaard gaan worden bekeken.

7 Oct 2019

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31 Jan 2020

PwC Scale: Life Sciences

Bridging the gap between the start-up ecosystem and corporate world to accelerate change and innovation

4 Oct 2019

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25 Oct 2019

Start2farma: cGMP & QMS Training (0 – 2 jaar ervaring)

Voor professionals die nieuw zijn in de industrie, geeft deze opleiding een goed overzicht van de regulatorische context binnen een (bio-) farmaceutische of biomedische werkomgeving en de vereiste kwaliteitssystemen.

20 Sep 2019

START2PHARMA: GMP-introductie voor operatoren en analisten

Deze opleiding geeft aan operationele medewerkers een goed begrip en bewustwording van het belang van kwaliteit en GMP in farmaceutische of biomedische werkomgeving. Deze GMP-introductie is een zeer praktische training. Naast het overzicht van de algemene principes en kwaliteitssystemen, staan we stil bij de praktische skills van “GMP en GLP” werken binnen GMP-omgevingen, “GDP” goed documenteren en de principes van omkleden en algemene kennis rond hygiëne.

Project engineers en leidinggevenden verwijzen we graag door naar de GMP-, QMS- en GLP-training waarin we echt naar de wetgeving gaan kijken en informatie geven op systeem en procedure niveau. 

16 Sep 2019

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17 Sep 2019

BE Synthetic Biology (Doctoral School Interuniversity Initiative)

The BE Synbio meeting will be a 2-day workshop for post-graduate students and early career post-doctoral researchers focused on the fields that support Synthetic Biology: microbiology, metabolic engineering, directed evolution, modelling and control theory.

12 Sep 2019

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28 Nov 2019

Belgian Medtech Booster

We want to boost the MedTech innovation and the emergence of new projects, capitalizing on the know-how, resources and networks available in the Flemish and Walloon territory.

24 Jun 2019

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5 Jul 2019

SCK•CEN Space summer school

For more than 15 years, SCK•CEN plays an important role in the pioneering research to enable future human space exploration, for example to the Moon or Mars. We are actively contributing to several space flight experiments as well as numerous Earth-based space analogs.

18 Jun 2019

How to Hold Your First-In-Human Trial?


“How to Hold Your First-In-Human trial?” is a clinical trial workshop bringing together experts in the field from Johnson & Johnson, CROs and research centres to discuss advantages, challenges and experiences in running trials around the globe.

11 Mar 2019

Start2Pharma: Basis GMP introductie

Voor nieuwkomers in de industrie, geeft deze opleiding een bewustwording en goed begrip van het belang van kwaliteit en GMP die hiertoe leidt in farmaceutische of biomedische werkomgeving.

28 Feb 2019

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1 Mar 2019

How to scale and go-to-market successfully

JLABS and Mimetis Biomaterials in partnership with Growth Erasmus+ European Project


Invites you to take part in a two-day masterclass in Growing a Life Sciences Company.

11 Feb 2019

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22 Feb 2019

Course: Radiation-induced effects with particular emphasis on genetics, development, teratology, cognition as well as space-related health issues

In the framework of the H2020 European CONCERT project, a short course of two weeks duration on "Radiation-induced effects with particular emphasis on genetics, development, teratology, cognition as well as space-related health issues" is organized by the Academy of Nuclear Science and Technology of the Belgian Nuclear Research Centre. It is open to postgraduate students and researchers working in the European Union, who are interested in radiation research. This initiative facilitates and promotes training and education in support of the research programme in radiation protection in Europe, and also makes more widely available training opportunities in order to help attract top-level students into the field.

4 Feb 2019

Start2pharma: technical writing of wi’s

The aim of this course is to enhance the GMP writing skills of the participants to write clear, standardized, readable and visual work instructions, taking in account human error

25 Jan 2019

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22 Feb 2019

Start2pharma 2-days: CGMP & QMS for professionals with 0 – 2 years’ experience in the industry

Day 1: 25/01

This course will provide to professionals with little experience in the industry, a good overview of Regulatory context of working in a Pharmaceutical environment. The participants will become aware of the importance of working with GMPs and will learn how to find the GMPs they need. They will also learn the role of authorities, legislation & inspections in safeguarding pharmaceutical quality. This training can be an addition to the internal GMP training, where this program gives helicopter view and more background.

 

Day 2: 22/02

This course will provide to professionals with little experience in the industry, an overview of the importance of Quality systems in a Pharmaceutical environment & the relations between the different systems. This training is an addition to the internal QMS training, which focuses on the “how”. This training focusses more on the frameworks & background of QMS and high-level overview on how Quality is built in a drug product. In this specific session we will also teach more details on how to handle non-conformities.

25 Sep 2018

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26 Sep 2018

Business Developers Program for Life Sciences - Course

On 25 & 26 September 2018 the Business Developers Program (BDP) Course will take place at the EY office in Amsterdam. This BDP Course specifically aims at junior to mid-level BD professionals who are driven to expand their knowledge on the BD process and to strengthen their BD competences.

18 Sep 2018

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21 Sep 2018

BCCM training on preservation of micro-organisms

The preservation of biological material is of primary interest for research but also for industrial applications. It is the mission of the BCCM consortium not only to preserve, but also to offer quality controlled, characterised and documented biological material. BCCM also offers its expertise through services and partnership projects.

20 Apr 2018

Key Considerations in Health Care Product Development

The health care sector finds itself in the midst of a fundamental transformation. All elements in this ecosystem are on the move: new insights in science and technology are only accelerating, leading to a vast number of innovations as never seen before; the image of how a ‘total health care solution’ will look like, is becoming more and more concrete; regulatory bodies are reconsidering their regulations, trying to keep pace with the speed of the evolutions; private and public health care insurers are looking for new models; patients and patient communities claim their role as active stakeholder; Life Sciences companies are seeking for a new position in the playing field, faced with an expanding number of new entrants, competitors and collaboration partners, …

26 Feb 2018

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27 Feb 2018

Bridging Preclinical and Clinical Development

The safety of the subject in any clinical trial is of paramount consideration. First in Human studies are special in this case as no data is available on how the investigational product will react in the human body. Preclinical data needs to be adequate to allow translation into a clinical study complying with all medical, scientific, ethical and regulatory aspects. Historical cases have shown that bridging preclinical and clinical is not always been adequate. The gap first needs to be understood and then strategies need to be developed to enable a smooth translation of the preclinical data of “research in animals” to the clinical research with First in Human studies.

8 Nov 2017

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10 Nov 2017

Pharmacokinetics in Drug Development - 2017

This course will focus on the physiochemical properties underlying the pharmacokinetics of a drug, will give insight in the calculation and interpretation of the pharmacokinetic parameters and will also explain the importance and application of pharmacokinetics in preclinical and clinical drug development.

12 Oct 2017

Key Considerations in Health Care Product Development

The health care sector finds itself in the midst of a fundamental transformation. All elements in this ecosystem are on the move. Life Sciences companies are seeking for a new position in the playing field, faced with an expanding number of new entrants, competitors and collaboration partners, …

22 Sep 2017

BCCM training: New developments in gene and plasmid technology

Scientific talks on:

  • "Plasmids for expression of recombinant proteins"
  • "Lentiviral gene delivery: a versatile and powerful tool in biomedical research"
  • "Genome editing: CRISPR/CAS and other concepts"
  • "Plasmids for in vivo (mouse) gene targeting"
  • "Genetic expression as a powerful tool for imaging“

11 Sep 2017

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15 Sep 2017

International Course: Principles of Biosafety

People responsible for biosafety and biorisk management in an organization have to cope with an increasing complexity and diversity of topics. This international course provides a comprehensive review of all essential elements of risk assessment and risk management (Part 1) and highlights topics indispensable for biosafety practitioners to fulfil their tasks (Part 2).

12 Jul 2017

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6 Sep 2017

Leadership Seminar: Wednesdays in the Summer: Why DNA and Talent do matter

During four workshops people managers get injected with skills to detect, attract, grow, engage and retain talent in their state-of-the-art and future oriented organisations. By making use of all five senses during practical workshops, people managers are triggered and inspired to reflect on work culture and employee engagement. 

29 Jun 2017

Software as a Medical Device

Medical devices are increasingly used in data and data applications. App developers are, as they should,  primarily focusing on development of their products while questions concerning quality are sometimes left out of scope. Once companies and their products finally go to market, critical quality issues may rise and therefore stand in the way of an efficient go-to-market or broadening of market potential.

 

A lean ISO13485:2016 certified QMS system can provide an efficient solution.