PQM+ & COVID-19
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, and dietary supplements manufactured, distributed, and consumed worldwide. In Pakistan, Promoting the Quality of Medicines Plus (PQM+) Program is a Cooperative Agreement between the United States Agency for International Development (USAID) and USP. This cooperative relationship supports the Drug Regulatory Authority of Pakistan (DRAP) for regulatory reforms, quality assurance systems, and strengthening the quality control laboratories in Pakistan. Moreover, PQM+ also provides technical capacity building in close coordination with DRAP and provincial health authorities.
ACTIVITY OBJECTIVE:
PQM+ team intends to conduct training on CE-Mark Certification for PPE manufacturers and the PQM+ team, in order to ensure PPE manufacturers’ products conform to health, safety, and environmental protection standards. This European Certification also ensures good quality PPE manufacturing by the manufacturers. This training will help to improve PPE manufacturers’ level of awareness on international standards & CE Certifications. For the said activity, PQM+ requires hiring a third-party consultant/firm to conduct the training accordingly.
1. To develop appropriate training materials on CE-Mark certification (all levels)
2. To conduct training sessions on CE-Mark certification (all levels) regulatory requirements for DRAP and PQM+ team.
3. To conduct training on CE-Mark Certification (all levels) for PPE manufacturers, for understanding and better compliance.
4. To guide and assist PPE manufacturer in filing applications to obtain CE Mark for products.
5. To ensure that all pre and post-training activities including training evaluations, training feedback is planned and executed professionally and timely.
6. To develop training reports on PQM+ reporting format.
MANDATORY DELIVERABLES:
- - Training reports
- - Training materials
- - Pre and post-training evaluations
- - Participant training feedback
- - Guidance document for CE Mark for products
MINIMUM REQUIREMENTS
1. At least 05 Years’ experience in conducting training for CE Mark Certifications.
2. Hands-on experience and work, with an excellent understanding of CE Mark Certifications.
3. Firm should be authorized to issue training certificates.
4. Proven leadership skills in consulting, with demonstrated experience in training and mentoring staff and others.
PERIOD OF PERFORMANCE
The scope of the work defined herein should be implemented before 30th June 2021. The assignment will be required 10 Working Days Level of Effort (LOE).
GEOGRAPHIC AREA
Selected firm/ individual will develop and work in consultation with the USP Pakistan team and deliver training at venue TBD.
REPORTING
Selected firm/ individual will report to the PQM+ Deputy Chief of Party.
EVALUATION CRITERIA
1. Past Experience - 30%
2. Qualification and Education - 30%
3. Financial Proposal- 40%
