Workshop «The new order for examination of drugs registration dossier: experience of the first half-year»

DEARFRIENDS!

On 16th April 2013 the order by the Ministry of Health of Ukraine dated 04/01/2013 No. 3 came into force. Pursuant to this act the order by the Ministry of Health of Ukraine dated 26/07/2005 No. 426 “On Approval of the Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products Submitted for state registration (re-registration), as well as testing kits for changes in registration materials during the registration certificate” has been set forth in new wording.

The new order approves the Procedure for carrying out expert examination of registration materials on medicines, including medical immunobiological preparations submitted for state registration (re-registration), as well as expert examination of materials on changes in registration materials during the term of the registration certificate.

Considering the mentioned changes Legal Alliance Company invites you to attend a workshop, scheduled on 2nd October 2012 (Wednesday) from 14.00 till 18.00 with the participation of experts and developers of the document:

THE NEW ORDER

FOR EXAMINATION OF DRUGS REGISTRATION DOSSIER:

experience of the first half-year

Venue: RAMADA ENCORE KIEV (103, Stolichnoe Shosse, 03131, Kiev. Conference Hall Vienna-Vilnius)

Language: Russian

Expert examination of the registration dossier is an important stage before making a decision on the state registration of any medicine. The new procedure for carrying out examination is aimed at implementing new approaches to this complex and important procedure. It provides for a new format for submission of documents, a clear sequence of stages of carrying out expert examination, updated approach to the determination of bioequivalence, new requirements for the form and content of the dossier submitted for carrying out expert examination, new requirements for the expert examination of registration materials on medical immunobiological preparations, innovations in the field of expert examination of biosimilars, etc.

It is important for applicants to know and understand the new procedure for carrying out expert examination and all its specific features for the purpose of the correct execution of registration materials, optimization of activities for the successful completion of all stages of the expert examination and the State Expert Center’s positive assessment (recommendations) of the possibility of carrying out state registration of the medicine by the Ministry of Health of Ukraine.

The event will be useful for managers of pharmaceutical companies involved in the process of drug registration.

SPEAKERS:

	OLGA BAULA The Adviser to the Minister of Health of Ukraine, the Chairman of the Scientific and expert and scientific and technical councils of the State Expert Center of the Ministry of Health of Ukraine. Since 1996, Ms. Baula has worked in the domain of the state registration of medicines, has gone from being an expert in registration dossier from 1996 to 2005 to the first deputy director of the State Expert Center of the Ministry of Health of Ukraine from 2007 to 2011.Member of the working group of the Ministry of Health of Ukraine on developing the Procedure for carrying out expert examination of registration materials on medicines.
	OLEKSANDR IANEV Associate with Legal Alliance Company. An expert of pharmaceutical regulatory practice. Mr. Ianev has a vast experience of executing projects with regard to the rule-making, analysis of regulations, pricing, clinical trials, registration and re-registration of medicinal products, import licensing and GMP-certification. .
	MODERATOR. DMYTRO ALESHKO Partner with Legal Alliance Company. Has been practicing law since 1994 and has extensive experience in medical law, regulatory issues related to the industries of pharmaceuticals and medical products. In 2003-2005. Mr. Aleshko served as Head of the Legal Department of the Ministry of Health of Ukraine. In 2010-2012 – was a Deputy Head of the General Directorate of Health KSCA on legal and personnel matters. Dmytro Aleshko was awarded with the diploma for a significant contribution to the development of health care and professionalism. He is currently the vice-president of the Association "The operators of the market of medical devices."

PROGRAMM:

• Overview of the examination registration materials for medicinal products submitted for state registration.
• A new approach to the evaluation of the registration dossier of generic drugs.
• Requirements for registration materials for similar biologicals (biosimilars).
• Expert evaluation on the combination of immunobiological drugs substances, medicines in the form of in-bulk, active pharmaceutical ingredients (APIs)
• The algorithm of passing the examination of materials registration and making decision of registration (re-registration).
• The procedure for making changes to the materials in the registration dossier during the rvalidity of registration certificate.
• Requirements for registration materials in accordance with different types of applications for state registration.
• Difficulties in distinguishing mandatory and optional documents in the overall package of documents submitted for medicinal products examination registration (with their registration, re-registration and amendments)
• Discussion of the challenges of passing the examination for registration materials for medicines. Search for the best solutions

FINANCIAL CONDITIONS:

REGISTRATION FORM & ENQUIRIES:

Please complete the registration form by link:

http://www.legalalliance.com.ua/rus/events

If you have any questions about registration or participation, please call Nataliia Duginova on +380 44 220 15 84 or e-mail duginova@l-a.com.ua.

CANCELLATION POLICY:

The participant may cancel his registration by 20 September, 2013 without any payments. Cancellations and refund requests must be received in writing and emailed on duginova@l-a.com.ua. All cancelations received after20 September, 2013, cannot be refunded and the full amount of your fee remains payable. We welcome substitute delegates if the registered delegate cannot attend. Contact duginova@l-a.com.ua. before the opening date of the workshop to give notice of substitute delegates. After this date no substitute delegates will be accepted. By submitting the registration form you confirm that you have read and understand this policy and you agree to be bound by them.

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