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Сalendar of events

We open up own training center, which will be the basis for sharing our experience and knowledge in area of regulatory and other affairs.

We are eager to achieve more effective and qualitative training process, for that number of participators for some seminars will be limited up 10 persons.
Do not hesitate, have time to register!

 

Seminars agenda for I half-year 2020:

January 24, Friday

from 09:30 up to 13:00

 

Cost: 1200.00 UAH (VAT is not included)

 

Speakers:

  • Anna Hnatiuk
  • Alla Somyk

Conformity assessment for medical devices of I class and medical devices for in vitro diagnostic, categorized as ‘others’.

Registration of persons responsible for the introduction of medical devices.

1. How to classify medical devices of I class and medical devices for in vitro diagnostic, categorized as ‘others’?

Whether risk class of devices depends on its scope of use. Borderline products.

2. List of necessary documentation. Storage of documentation by Authorised representative: timelines, form etс.

3. Conduction of conformity assessment procedure.

4. MOH Order №122 on maintenance of Register of persons, responsible for introduction of medical devices. Entering in the Register. Specific requirements and the most frequent observations.

Registration >>


 

February 13, Thursday

from 09:30 up to 13:00

 

Cost: 1400.00 UAH (VAT is not included)

 

Speakers:

  • Inna Kapytsia

Requirements for legalization and labeling of food products in Ukraine.

1. Legal requirements to enter food products into circulation. Mandatory and voluntary procedures.

2. New labeling requirements as approved by Law of Ukraine ‘On information about food products for consumers’.

3. Application of SI units on labeling.

4. HACCP for market operators.

5. State market surveillance.

 

Registration >>


 

February 21, Friday

from 09:30 up to 13:00

 

Cost: 1500.00 UAH (VAT is not included)

 

Speakers:

  • Alla Somyk
  • Yulia Vertyaeva

Labeling of medical devices: Technical regulations, Law on language, SI units and other legal acts.

1. Legal requirements to labeling of medical devices: technical regulations, Law on language and other acts;

2. Impact of the Law on the labeling requirements, instructions, user interface and accompanying documentation of medical devices;

3. Order of Ministry for economic development of Ukraine dated August 4, 2015 № 914 ‘About approval of definition of main SI units’;

4. Special requirements to different types of devices.

5. Common mistakes.

Registration >>


 

February 27, Thursday

from 10:00 up to 13:00

 

Cost: 2500.00 UAH (VAT is not included)

 

Speakers:

  • Maksym Bagreev
  • Kateryna Liukhanova (involved expert)

Fight against gray import and counterfeiting on the medical device market

1. Counterfeit, gray import and fabrication;

2. Informing is the first step to protecting.

3. How to communicate to the manufacturer the need to act;

4. Trademark: license agreement, entering into customs register and other protection tools;

5. Authorised Representative's authority and regulatory ways of protection;

6. Bodies of state market surveillance;

7. Methods of control and removal from circulation of gray imports.

8. Practical advice for manufacturers and authorised representatives.

Registration >>


 

March 12, Thursday

from 09:30 up to 13:00

 

Cost: 1200.00 UAH (VAT is not included)

 

Speakers:

  • Anna Hnatiuk
  • Alla Somyk

Authorised representative in Ukraine. Experience in dealing with inspections of market surveillance body.

1. Function and change of Authorised representative of manufacturer in Ukraine.

2. Duties of Authorised representative. List of technical documentation to be stored.

3. How to prepare to inspections from market surveillance body’s side.

4. Experience in participating in market surveillance of medical devices.

 

Registration >>


 

March 27, Friday

from 09:30 up to 13:00

 

Cost: 1200.00 UAH (VAT is not included)

 

Speakers:

  • Igor Yurchenko
  • Alla Somyk

Conformity assessment: audit of production or recognition of EC Certificates results.

1. Conformity assessment through audit of production: stages and necessary documentation.

2. Procedure of recognition of EC Certificates: legal basis, necessary conditions, list of documents.

3. Surveillance audits as part of conformity assessment.

4. Features of re-certification procedure.

5. The procedure for making changes to certificates of conformity.

 

Registration >>


 

April 10, Friday

from 09:30 up to 13:00

 

Cost: 1200.00 UAH (VAT is not included)

 

Speakers:

  • Igor Yurchenko
  • Anna Hnatiuk

Complex application of Technical regulations №355 (RED) and №139 (RoHS2) for medical devices.

1. Essential requirements of Technical regulation on radio-equipment (TR №355).

2. Essential requirements of Technical regulation on restrictions of use of hazardous substances in electrical and electronic equipment (ТR №139);

3. Declaration of conformity to Technical regulations №355 and №139.

4. Features of the labeling of products covered by several Technical Regulations.

5. Identification of subjects to market surveillance and their responsibilities.

Registration >>


 

April 24, Friday

from 09:30 up to 13:00

 

Cost: 1400.00 UAH (VAT is not included)

 

Speakers:

  • Igor Yurchenko
  • Yulia Vertyaeva

Introduction of MDR in European Union. Main differences between MDR and MDD.

1. Essential requirements of MDR. Transition period.

2. Changes in classification of medical devices.

3. Implementation of requirements to distributors, Authorised representative and importer.

4. Comparison and main differences between MDR and MDD.

5. Impact of implementation of new directives on conformity assessment procedures in Ukraine.

 

Registration >>


 

May 15, Friday

from 10:00 up to 13:00

 

Cost: 1200.00 UAH (VAT is not included)

 

Speakers:

  • Alla Somyk
  • Kateryna Liukhanova (involved expert)

Conduction of post-market activities for medical devices. Notification on accidents.

1. Brief review of legal acts of Ukraine and EU regarding conduction of post-marketing activity.

2. What have to be notified to conformity assessment body and State administration on medicines and drugs control?

3. Gathering of information on products, introduced into circulation on the territory of Ukraine.

4. Notification on accidents.

 

Registration >>


 

We look forward to seeing you at our seminars!