The Predicted Impact of the ISO IDMP Standards Implementation Process Carried Out by the European Medicines Agency

By | news1

The IDMP is a general term by which the 5 ISO data standards are referenced: ISO 11615 (regulated medicinal product information), ISO 11616 (regulated pharmaceutical product information), ISO 11238 (substances), ISO 11239 (pharmaceutical dose forms, units of presentation, routes of administration and packaging) and ISO 11240 (units of measurement). – which are being refined and implemented by regulatory bodies.

Read More

5 things you need to know about running a clinical study in the Baltic states

By | news1

In the past five years, an average of 175 clinical trials are being initiated in the Baltic states each year. An average of 64,8% of the population in the Baltic states are in the age from 15 to 65 years old, the main target audience for clinical trials. Furthermore, a large pool of treatment-naïve subjects is available compared to other EU countries or the US. Patients with special therapeutic diseases are transferred to the main central hospitals.

Read More
Monika Staniulytė, MPharm

Falsified Medicines Directive Implementation – Marketing Authorization Holder Perspective

By | news1

Falsified Medicines Directive (FMD) 2011/62/EU which aims to increase the security of manufacturing and delivery of medicines across Europe as well as protect patients and prevent falsified medicines from entering the supply chain has come in force Feb 9th, 2019. With the first quarter almost over, it is a great opportunity to look back and share the experience. The new requirements for safety features to appear on the packaging of all prescription medicines.

Read More
Filip Risteski, Chief Financial Officer at Biomapas

Biomapas appoints Chief Financial Officer

By | news2

Filip Risteski was recently appointed as Chief Financial Officer (CFO) at Biomapas and will be one of the key players further strengthening continued growth of Biomapas. Filip will report directly to Audrius Sveikata, Biomapas Chief Executive Officer. As a CFO he will be responsible for placing control over finance function and financial strategy, by maximizing efficiency and ensuring highest quality standards. Furthermore, Filip will work with a management team on implementation of overall company business strategy.

Read More
Monika Lakytė, HR Director at Biomapas

Biomapas appoints Director of Human Resources

By | news2

In order to support the continued growth of Biomapas, the company has appointed a Director of Human Resources, Monika Lakytė. “We are excited to have Monika as a member of our management team. She shares our values and our focus on future goals, her professional experience in recruitment process and personnel management will endorse our continued growth. People as Monika is the result of highest quality standards in our work,” said Juozas Buitkus, Biomapas COO.

Read More
Pharmacovigilance Brexit

Remaining Vigilant and Compliant after Brexit: What’s next? (Latest Updates)

By | news2

On 29th March 2017 UK submitted the notification of its intention to withdraw from the EU. This means that UK will become a ‘third country’ from 30th March’19. Even though leaving the EU with a deal remains the Government’s top priority, UK drug agency is publishing a series of guidance documents for industry and other stakeholders covering the proposed arrangements for the regulation of medicines, medical devices and clinical trials, if UK leaves EU with no deal.

Read More

Tuberculosis Medicines Clinical Development in Eastern Europe and CIS

By | news3

World Tuberculosis Day is commemorated every year on 24th March to raise awareness of tuberculosis, which is still causing death of nearly 1.5 million people each year, mostly in developing countries. It marks the day in 1882, when Dr. Robert Koch announced that he had discovered the cause of tuberculosis, the TB bacillus. In comparison to other infectious diseases caused by a single infectious agent, tuberculosis is the second biggest killer worldwide.

Read More

Changing regulatory environment: eCTD submissions to become obligatory as of 2018

By | news3

A new challenge is about to be faced by the MAHs of medicinal products. Since online tools are becoming a bigger part of our daily lives, the competent authorities are also moving forward step by step. 1st Jan 2018, the European Medicines Agency will require that all regulatory submissions for medicinal products authorized via Decentralized or Mutual Recognition Procedure will be provided in eCTD format.

Read More

Biomapas Receives CIR (French Research Tax Credit) Accreditation

By | News, news3

Biomapas a annoncé récemment avoir reçu de la part du Ministère de l’enseignement supérieur et de la recherche l’accréditation Crédit d’Impôt Recherche (CIR) pour une période de trois ans.

Biomapas has recently announced that it has received Research Tax Credit (Crédit d’Impôt Recherche; CIR) accreditation for a three-year period from the French Ministry of Higher Education and Research.
.

Read More

Harmonization of EAEU GVP: CIS is getting more vigilant than ever before

By | news4

On the 6-7 March, Biomapas Pharmacovigilance Department management and team from the CIS region participated in a meeting in Minsk. It was dedicated to strengthening collaboration between the team members as well as updating knowledge on latest PV trends. We discussed the most recent releases of legislation, such as Eurasian Economic Union Good Pharmacovigilance Practice harmonization and the importance of a teamwork approach with Biomapas’ PV Project Manager CIS, Aliaksandr Bakshtanovich, MD.

Read More

Biomapas announces the opening of a new office in Sweden

By | News, news4

Biomapas has recently announced the opening of a new office in Stockholm, Sweden. This new location strengthens Biomapas’ presence in the Nordic countries and further accommodates the rapid growth of the company.

The expansion into the Nordics is in direct response to demand from Biomapas clients seeking local Regulatory and Pharmacovigilance support. The company already has offices in Switzerland, Lithuania, Russia, Georgia and Ukraine.

Read More

Implementation of ISO 9001 and 13485 standards: what does it bring to company and clients?

By | news4

Compliance with high quality standards is a non-negotiable performance parameter in Pharmaceutical and Medical Device industries. During 2016, Biomapas was re-certified according to the newest ISO 9001 standard version. Moreover, at the beginning of 2017, ISO 13485 implementation into BIOMAPAS Quality Management System was initiated. We discussed the influence of current changes to the whole company and its quality management with Egidija Pauriene, MD, Quality Assurance Director.

Read More

Biomapas receives Knowledge Economy Company 2016 award

By | news5

26th January, 2016 Biomapas representatives attended the Knowledge Economy Forum award ceremony at the Presidential Palace of the Republic of Lithuania. The Knowledge Economy Company awards are granted each year from 2004 in order to honor the most progressive and innovative companies operating in Lithuania, creating high value-added products or services. The awards are patronized by the President of the Republic of Lithuania Dalia Grybauskaitė.

Read More

Lithuania intends to take on the RMS role from UK for 70 Mutual Recognition and Decentralised Procedures

By | news5

The United Kingdom (UK) submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union (EU). This means that the United Kingdom will become a ‘third country’ from 30 March 2019.
According to Directive 2001/83/EC the reference member state (RMS) must be a member of the EU. As a result the RMS role in Mutual Recognition and Decentralised Procedures (MRP/DCP) must be transferred to an EU country.

Read More
Egle Pavyde, Mpharm, PhDc, Business Development Director

CIS and Eurasian Economic Union: high Pharma industry interest and new legislation

By | news5

The interest of pharmaceutical companies in expanding business across CIS region has been constantly growing. For the same reason, Biomapas has expanded presence and now covers the whole CIS region, providing core services: clinical research, regulatory affairs, pharmacovigilance.
Associate Director Business Development Egle Pavyde, shares some thoughts about region peculiarities, recent legislation changes and Biomapas experience providing RA and PV services in CIS.

Read More

Biomapas: Improving the Document Review Process

By | news5

Biomapas currently covers 64 countries across Europe, CIS and MENA regions. Being able to provide clinical trial, regulatory affairs, medical writing and vigilance solutions to all of these countries requires us to have a large repertoire of native speakers on staff.

Since providing top quality work to our customers has always been of paramount importance for Biomapas, we needed a way to ensure document accuracy, and therefore decided to look at proofreading software to help us maintain quality.

Read More
Audrius Sveikata, MD, PhD, Chief Executive Officer

AICROS Annual Meeting: insights and future perspectives

By | news5

The Association of International Clinical Research Organizations (AICROS) is a network of small to mid-size CROs, which provide clinical research services to the pharmaceutical, biotech and medtech industries. Biomapas joined AICROS in 2014 and since then has been an active member of the association. On the 20-22 February, Biomapas’ CEO Audrius Sveikata participated in the AICROS Annual meeting, which took place in Tel Aviv, Israel. Audrius shared his insights about the meeting and the future perspectives of the association.

Read More

Biomapas is attending or exhibiting at the following events during 2019

CONTACT US FOR AN APPOINTMENT

BIO International Convention, Philadelphia, USA. 3rd – 6th June 2019.

BIO International Convention, Philadelphia, USA. 3rd – 6th June 2019.

request-meeting2019

The International Pharmacovigilance Day conference, Barcelona, Spain. 12th – 13th June 2019.

request-meeting2019

Nordic Life Science Days, Malmö, Sweden. 10th – 12th September 2019.

Nordic Life Science Days, Malmö, Sweden. 10th – 12th September 2019.

request-meeting2019

Convergence in Oncology Summit, Biopôle Lausanne, Switzerland. 12th – 13th September 2019.

Convergence in Oncology Summit, Biopôle Lausanne, Switzerland. 12th – 13th September 2019.

request-meeting2019

World drug safety congress Europe, Amsterdam, The Netherlands. 10th – 11th September 2019.

World drug safety congress Europe, Amsterdam, The Netherlands. 10th – 11th September 2019.

request-meeting2019

European Society for Medical Oncology Congress, Barcelona, Spain. 27th September – 1st October 2019.

European Society for Medical Oncology Congress, Barcelona, Spain. 27th September – 1st October 2019.

request-meeting2019

Medtech and Pharma Platform, Basel, Switzerland. 24th – 25th October 2019.

Medtech and Pharma Platform, Basel, Switzerland. 24th – 25th October 2019.

request-meeting2019

TOPRA Annual Symposium, Dublin, Ireland. 30th September – 2nd October 2019.

TOPRA Annual Symposium, Dublin, Ireland. 30th September – 2nd October 2019.

request-meeting2019

CPhI Worldwide, Frankfurt, Germany. 5th – 7th November 2019.

CPhI Worldwide, Frankfurt, Germany. 5th – 7th November 2019.

request-meeting2019

Bio-Europe, Hamburg, Germany. 11th – 13th November 2019.

Bio-Europe, Hamburg, Germany. 11th – 13th November 2019.

request-meeting2019

Clinical Trials Russia, Moscow, Russia. 26th – 27th November 2019.

Clinical Trials Russia, Moscow, Russia. 26th – 27th November 2019.

request-meeting2019

Genesis conference, London, UK. 11th December 2019.

Genesis conference, London, UK. 11th December 2019.

request-meeting2019

The Predicted Impact of the ISO IDMP Standards Implementation Process Carried Out by the European Medicines Agency

By | news1

The IDMP is a general term by which the 5 ISO data standards are referenced: ISO 11615 (regulated medicinal product information), ISO 11616 (regulated pharmaceutical product information), ISO 11238 (substances), ISO 11239 (pharmaceutical dose forms, units of presentation, routes of administration and packaging) and ISO 11240 (units of measurement). – which are being refined and implemented by regulatory bodies.

Read More

5 things you need to know about running a clinical study in the Baltic states

By | news1

In the past five years, an average of 175 clinical trials are being initiated in the Baltic states each year. An average of 64,8% of the population in the Baltic states are in the age from 15 to 65 years old, the main target audience for clinical trials. Furthermore, a large pool of treatment-naïve subjects is available compared to other EU countries or the US. Patients with special therapeutic diseases are transferred to the main central hospitals.

Read More
Monika Staniulytė, MPharm

Falsified Medicines Directive Implementation – Marketing Authorization Holder Perspective

By | news1

Falsified Medicines Directive (FMD) 2011/62/EU which aims to increase the security of manufacturing and delivery of medicines across Europe as well as protect patients and prevent falsified medicines from entering the supply chain has come in force Feb 9th, 2019. With the first quarter almost over, it is a great opportunity to look back and share the experience. The new requirements for safety features to appear on the packaging of all prescription medicines.

Read More
Filip Risteski, Chief Financial Officer at Biomapas

Biomapas appoints Chief Financial Officer

By | news2

Filip Risteski was recently appointed as Chief Financial Officer (CFO) at Biomapas and will be one of the key players further strengthening continued growth of Biomapas. Filip will report directly to Audrius Sveikata, Biomapas Chief Executive Officer. As a CFO he will be responsible for placing control over finance function and financial strategy, by maximizing efficiency and ensuring highest quality standards. Furthermore, Filip will work with a management team on implementation of overall company business strategy.

Read More
Monika Lakytė, HR Director at Biomapas

Biomapas appoints Director of Human Resources

By | news2

In order to support the continued growth of Biomapas, the company has appointed a Director of Human Resources, Monika Lakytė. “We are excited to have Monika as a member of our management team. She shares our values and our focus on future goals, her professional experience in recruitment process and personnel management will endorse our continued growth. People as Monika is the result of highest quality standards in our work,” said Juozas Buitkus, Biomapas COO.

Read More
Pharmacovigilance Brexit

Remaining Vigilant and Compliant after Brexit: What’s next? (Latest Updates)

By | news2

On 29th March 2017 UK submitted the notification of its intention to withdraw from the EU. This means that UK will become a ‘third country’ from 30th March’19. Even though leaving the EU with a deal remains the Government’s top priority, UK drug agency is publishing a series of guidance documents for industry and other stakeholders covering the proposed arrangements for the regulation of medicines, medical devices and clinical trials, if UK leaves EU with no deal.

Read More

Tuberculosis Medicines Clinical Development in Eastern Europe and CIS

By | news3

World Tuberculosis Day is commemorated every year on 24th March to raise awareness of tuberculosis, which is still causing death of nearly 1.5 million people each year, mostly in developing countries. It marks the day in 1882, when Dr. Robert Koch announced that he had discovered the cause of tuberculosis, the TB bacillus. In comparison to other infectious diseases caused by a single infectious agent, tuberculosis is the second biggest killer worldwide.

Read More

Changing regulatory environment: eCTD submissions to become obligatory as of 2018

By | news3

A new challenge is about to be faced by the MAHs of medicinal products. Since online tools are becoming a bigger part of our daily lives, the competent authorities are also moving forward step by step. 1st Jan 2018, the European Medicines Agency will require that all regulatory submissions for medicinal products authorized via Decentralized or Mutual Recognition Procedure will be provided in eCTD format.

Read More

Biomapas Receives CIR (French Research Tax Credit) Accreditation

By | News, news3

Biomapas a annoncé récemment avoir reçu de la part du Ministère de l’enseignement supérieur et de la recherche l’accréditation Crédit d’Impôt Recherche (CIR) pour une période de trois ans.

Biomapas has recently announced that it has received Research Tax Credit (Crédit d’Impôt Recherche; CIR) accreditation for a three-year period from the French Ministry of Higher Education and Research.
.

Read More

Harmonization of EAEU GVP: CIS is getting more vigilant than ever before

By | news4

On the 6-7 March, Biomapas Pharmacovigilance Department management and team from the CIS region participated in a meeting in Minsk. It was dedicated to strengthening collaboration between the team members as well as updating knowledge on latest PV trends. We discussed the most recent releases of legislation, such as Eurasian Economic Union Good Pharmacovigilance Practice harmonization and the importance of a teamwork approach with Biomapas’ PV Project Manager CIS, Aliaksandr Bakshtanovich, MD.

Read More

Biomapas announces the opening of a new office in Sweden

By | News, news4

Biomapas has recently announced the opening of a new office in Stockholm, Sweden. This new location strengthens Biomapas’ presence in the Nordic countries and further accommodates the rapid growth of the company.

The expansion into the Nordics is in direct response to demand from Biomapas clients seeking local Regulatory and Pharmacovigilance support. The company already has offices in Switzerland, Lithuania, Russia, Georgia and Ukraine.

Read More

Implementation of ISO 9001 and 13485 standards: what does it bring to company and clients?

By | news4

Compliance with high quality standards is a non-negotiable performance parameter in Pharmaceutical and Medical Device industries. During 2016, Biomapas was re-certified according to the newest ISO 9001 standard version. Moreover, at the beginning of 2017, ISO 13485 implementation into BIOMAPAS Quality Management System was initiated. We discussed the influence of current changes to the whole company and its quality management with Egidija Pauriene, MD, Quality Assurance Director.

Read More

Biomapas receives Knowledge Economy Company 2016 award

By | news5

26th January, 2016 Biomapas representatives attended the Knowledge Economy Forum award ceremony at the Presidential Palace of the Republic of Lithuania. The Knowledge Economy Company awards are granted each year from 2004 in order to honor the most progressive and innovative companies operating in Lithuania, creating high value-added products or services. The awards are patronized by the President of the Republic of Lithuania Dalia Grybauskaitė.

Read More

Lithuania intends to take on the RMS role from UK for 70 Mutual Recognition and Decentralised Procedures

By | news5

The United Kingdom (UK) submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union (EU). This means that the United Kingdom will become a ‘third country’ from 30 March 2019.
According to Directive 2001/83/EC the reference member state (RMS) must be a member of the EU. As a result the RMS role in Mutual Recognition and Decentralised Procedures (MRP/DCP) must be transferred to an EU country.

Read More
Egle Pavyde, Mpharm, PhDc, Business Development Director

CIS and Eurasian Economic Union: high Pharma industry interest and new legislation

By | news5

The interest of pharmaceutical companies in expanding business across CIS region has been constantly growing. For the same reason, Biomapas has expanded presence and now covers the whole CIS region, providing core services: clinical research, regulatory affairs, pharmacovigilance.
Associate Director Business Development Egle Pavyde, shares some thoughts about region peculiarities, recent legislation changes and Biomapas experience providing RA and PV services in CIS.

Read More

Biomapas: Improving the Document Review Process

By | news5

Biomapas currently covers 64 countries across Europe, CIS and MENA regions. Being able to provide clinical trial, regulatory affairs, medical writing and vigilance solutions to all of these countries requires us to have a large repertoire of native speakers on staff.

Since providing top quality work to our customers has always been of paramount importance for Biomapas, we needed a way to ensure document accuracy, and therefore decided to look at proofreading software to help us maintain quality.

Read More
Audrius Sveikata, MD, PhD, Chief Executive Officer

AICROS Annual Meeting: insights and future perspectives

By | news5

The Association of International Clinical Research Organizations (AICROS) is a network of small to mid-size CROs, which provide clinical research services to the pharmaceutical, biotech and medtech industries. Biomapas joined AICROS in 2014 and since then has been an active member of the association. On the 20-22 February, Biomapas’ CEO Audrius Sveikata participated in the AICROS Annual meeting, which took place in Tel Aviv, Israel. Audrius shared his insights about the meeting and the future perspectives of the association.

Read More

Biomapas is attending or exhibiting at the following events during 2019

CONTACT US FOR AN APPOINTMENT

BIO International Convention, Philadelphia, USA. 3rd – 6th June 2019.

BIO International Convention, Philadelphia, USA. 3rd – 6th June 2019. Request meeting.

The International Pharmacovigilance Day conference, Barcelona, Spain. 12th – 13th June 2019. Request meeting.

Nordic Life Science Days, Malmö, Sweden. 10th – 12th September 2019.

Nordic Life Science Days, Malmö, Sweden. 10th – 12th September 2019. Request meeting.

Convergence in Oncology Summit, Biopôle Lausanne, Switzerland. 12th – 13th September 2019.

Convergence in Oncology Summit, Biopôle Lausanne, Switzerland. 12th – 13th September 2019. Request meeting.

World drug safety congress Europe, Amsterdam, The Netherlands. 10th – 11th September 2019.

World drug safety congress Europe, Amsterdam, The Netherlands. 10th – 11th September 2019. Request meeting.

European Society for Medical Oncology Congress, Barcelona, Spain. 27th September – 1st October 2019.

European Society for Medical Oncology Congress, Barcelona, Spain. 27th September – 1st October 2019. Request meeting.

Medtech and Pharma Platform, Basel, Switzerland. 24th – 25th October 2019.

Medtech and Pharma Platform, Basel, Switzerland. 24th – 25th October 2019. Request meeting.

TOPRA Annual Symposium, Dublin, Ireland. 30th September – 2nd October 2019.

TOPRA Annual Symposium, Dublin, Ireland. 30th September – 2nd October 2019. Request meeting.

CPhI Worldwide, Frankfurt, Germany. 5th – 7th November 2019.

CPhI Worldwide, Frankfurt, Germany. 5th – 7th November 2019. Request meeting.

Bio-Europe, Hamburg, Germany. 11th – 13th November 2019.

Bio-Europe, Hamburg, Germany. 11th – 13th November 2019. Request meeting.

Clinical Trials Russia, Moscow, Russia. 26th – 27th November 2019.

Clinical Trials Russia, Moscow, Russia. 26th – 27th November 2019. Request meeting.

Genesis conference, London, UK. 11th December 2019.

Genesis conference, London, UK. 11th December 2019. Request meeting.