Resolution 75/2018 of the Center for the State Control of the Quality of Medicines and Medical Devices (CECMED) approves and enforces the Guide for the performance of pharmacogenomic studies during the development of medicines. According to CECMED, this guide is considered the first regulatory provision on the subject in the region. This provision sets the guidelines for conducting pharmacogenomic evaluations during the development of medicines of the national pharmaceutical industry.

The guide includes regulatory requirements for pharmacogenomic evaluation: the reception, coding and storage of samples, the use of biomarkers and the ethics of research. Pharmacogenomics allows therapeutic decisions to be guided by the molecular attributes of each patient, allows identifying patients who will respond to treatment, which implies an increase in therapeutic activity of incalculable scope, also has great impact in terms of safety, since the patients who will not respond, when not receiving the treatment, will be saved toxicities that would limit their quality of life, finally the impact on the efficiency, means a reduction of the direct costs of the medicines.

Source: CECMED, Dr. Diadelis Remirez (http://www.cecmed.cu/content/guia-para-la-realizacion-de-estudios-farmacogenomicos-primera-en-la-region)

Workshop with regulators from EU, Japan and US open for registration

The European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States’ Food and Drug Administration (FDA) are co-organising a workshop to discuss the development of antibiotics for children.

The workshop will take place at EMA’s premises in London on 21-22 June 2018.

It will provide an opportunity for international regulators to explore with medicine developers, clinicians and clinical trial investigators, clinical development plans that would allow for the timely development of antibiotics for children and discuss a regulatory pathway for their approval.

Expressions of interest to attend the event should be sent to paediatric.antibacterial.agents.workshop@ema.europa.eu by 6 June 2018. Places are limited and will be allocated in a way that ensures a fair representation of all stakeholder groups and organisations.

The workshop will be broadcast live on the EMA website. An agenda of the event is available.

In light of the emergence of antimicrobial resistance as a major global public health threat, there is an urgent need to develop new medicines to treat infections caused by bacteria that have become resistant to most antibacterial agents currently available. Children are also affected by infections caused by these resistant bacteria and are equally in need of new therapeutic options. As paediatric development often takes several years after initial approval of medicines in adults, timely planning and conduct of fit-for-purpose paediatric studies is key to generate sufficient evidence to allow regulatory decisions and ultimately timely access to antibiotics for children who need them.

Highlights to be discussed at the workshop include:

• challenges with conducting trials in children;
• extrapolation of safety and efficacy data to optimise the involvement of children in clinical studies; and
• studies in newborn babies.

(…)

For more information go to http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/05/news_detail_002960.jsp&mid=WC0b01ac058004d5c1

[Original text in Spanish]

NEW LABORATORY OF MEDICAL DEVICES WILL INCREASE AT 74% ANALYZED UNITS

National Accreditation Agency of Colombia (ONAC) granted accreditation to 21 methodologies under ISO / IEC 17025: 2005

The National Institute for Food and Drug Surveillance (INVIMA) today inaugurated the new facilities of its laboratory for quality control of medical devices, which will allow the institution to analyze more than 18 thousand samples a year, an increase of 74 percent in relation to previous years.

This modern laboratory went from 33 m2 to 88 m2, which meant increasing its capacity to perform analyzes on medical devices such as: condoms, syringes, gloves, sutures, peripheral intravenous catheters, macrogoteo equipment, among others.

On the other hand, the National Accreditation Agency of Colombia (ONAC) granted accreditation to 21 methodologies under ISO / IEC 17025: 2005, in reference to latex male condom tests, sterile latex gloves, syringes and hypodermic needles

“As a health agency in the country we are proud to have an accredited laboratory, a pioneer in the Americas region in conducting quality control tests for Medical Devices and generators of research and innovation for the technical-scientific development that you need Colombia, “said Guzmán Cruz.

He also added that with the strengthening of human talent, infrastructure and acquisition of new equipment in 2018, the Medical Physical Devices Laboratory, will apply new technologies designed to meet the quality specifications of medical devices and will maintain the risk approach to evaluate the products with the greatest impact on the health of Colombians.

The challenge continues in the implementation of increasingly demanding projects, which position laboratories as a fundamental axis in the framework of the responsibility of health surveillance and in the issue of quality control, safety and efficiency of medical devices.

Source: https://www.invima.gov.co/nuevo-laboratorio-de-dispositivos-m%C3%A9dicos-aumentar%C3%A1-en-74-unidades-analizadas.html

The Food and Drug Administration (FDA) is announcing the following public symposium entitled ‘‘2018 Center for Biologics Evaluation and Research Science Symposium.’’ The purpose of the public symposium is to discuss scientific topics related to the regulation of biologics and highlight science conducted at the Center for Biologics Evaluation and Research (CBER) by showcasing how scientific research informs regulatory decision making and to provide a forum for developing collaborations within FDA and with external organizations. The symposium will include presentations by experts from academic institutions, government agencies, and research institutions.

DATES

The public symposium will be held on June 25 and 26, 2018, from 9 a.m. to 3 p.m.

TOPICS FOR DISCUSSION

The public symposium will include presentations on the following topics:

(1) Emerging and re-emerging diseases;

(2) diverse types of data in regulatory decision making;

(3) immune response to vaccination;

(4) immunotherapy;

(5) new technologies for research and treatments; (6) the role of the microbiome in human disease; and

(7) regenerative medicine.

PARTICIPATON

Participating in the Public Symposium could be in person or by webast.

Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public symposium (either in person or by webcast) (see Streaming Webcast of the Public Symposium) must register online by June 18, 2018, midnight Eastern Time. Early registration is recommended because seating is limited. There will be no onsite registration; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted.

For more information go to https://www.gpo.gov/fdsys/pkg/FR-2018-03-22/pdf/2018-05805.pdf

The World Health Assembly The World Health Assembly (WHA) is the decision-making body of WHO.  It is attended by delegations from all WHO Member States and focuses on a specific health agenda prepared by the Executive Board.

The main functions of the World Health Assembly are to determine the policies of the Organization, supervise financial policies, and review and approve the proposed programme budget.

This year’s Health Assembly takes place on 21–26 May 2018 in Geneva, Switzerland.

Live at http://www.who.int/world-health-assembly/seventy-first

World Health +SocialGood: Show schedule

http://www.who.int/world-health-assembly/seventy-first/social-good 

Tuesday, 22 May

Bringing health to all

• Universal health coverage: what it means and how we can achieve it
• HIV/AIDS: achievements and challenges
• Smallpox: the story of eradication

Wednesday, 23 May

Keeping healthy in today’s world

• Air pollution
• Transfats
• Assistive technologies
• Maternal, child and adolescent health

Thursday, 24 May

Keeping the world safe, serving the vulnerable

• Ebola in the Democratic Republic of Congo
• Cox’s Bazar
• Vaccination to prevent and contain outbreaks
• EPI: the early days
• Influenza: prevention and control

For more information about the Seventy-first WHA, go to http://www.who.int/world-health-assembly/seventy-first