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Regulatory developments concerning Off-label and compassionate use of pharmaceutical products in Bulgaria

Regulatory developments concerning Off-label and compassionate use of pharmaceutical products in Bulgaria

Some recent regulatory changes related to the procedure for Off-label and compassionate use of medicinal products are expected to enter into force these says. Following a public consultation held between 9 February and 11 March 2022, on 31 May 2022 amendments to Ordinance No. 10 of 17 November 2011 on the conditions and procedure for […]

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Venelin Dimitrov, Ilya Komarevski and Mileslava Bogdanova – Misheva ranked by Chambers Europe 2022

Venelin Dimitrov, Ilya Komarevski and Mileslava Bogdanova – Misheva ranked by Chambers Europe 2022

KDP’s Venelin Dimitrov, Ilya Komarevski and Mileslava Bogdanova-Misheva top ranked in the new Chambers Europe 2022 guide in: Venelin Dimitrov is praised for his “great project management skills“. Clients also say he is an “excellent negotiator and deal maker. He is very experienced and diligent.“ Ilya Komarevski is praised for his “ability to understand the

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The new EU Clinical Trials Regulation entered into force. How will the provisions of this regulation interplay with the GDPR – an attempt for answer and more questions

The new EU Clinical Trials Regulation entered into force. How will the provisions of this regulation interplay with the GDPR – an attempt for answer and more questions

After several postponements of the implementation of Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use (“Clinical Trials Regulation”), the regulation entered into force on the last day of January 2022. One of the objectives of this Regulation is to ensure safe conduct of clinical trials,through which to generate reliable and

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You plan to transfer a receivable – have you obtained consent under the GDPR?

You plan to transfer a receivable – have you obtained consent under the GDPR?

The entry into force of the General Data Protection Regulation, also known in Bulgaria as the GDPR, aimed to provide new opportunities. For the clients, which are data subjects, this is the opportunity to have control over their personal information – who, where, how and why uses it. The GDPR has made it more difficult

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