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ABOUT US

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. USP’s focus on global public health extends to lower and middle-income countries with work in over 20 countries through donor-funded programs. Our programs are focused on building the capacity of regulatory authorities and manufacturers in ensuring patient access to quality-assured essential medicines by providing: 1) Technical assistance to manufacturers to increase the supply of quality-assured priority medicines for malaria, HIV/AIDS, tuberculosis (TB), neglected tropical diseases (NTDs), and maternal, newborn, and child health (MNCH) products; and 2) capacity-building activities to regulatory authorities to fulfill their function in ensuring the supply of quality-assured medical products.

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 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 OBECTIVE:

PQM+ team intends to conduct a 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 to hire 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 session on CE-Mark certification (all levels) regulatory requirement 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 for filling applications to obtain CE Mark for products.
  5. To ensure that all pre and post-training activities including training evaluations, training feedback are 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 trainings 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% 

IMPORTANT NOTE

The Consultant (Firm/Individual) is required to have the aforementioned professional and technical qualifications. Only the applicants who hold these qualifications will be shortlisted and contacted.

Please send CV/Profile, 3-References, and Daily Rate by downloading following ANNEX – D (Template):

https://drive.google.com/file/d/1SNQftPHB25vpRZTcznnsDrFRB8d2r7d1/view?usp=sharing

The Quoted Per Day Rate should be inclusive of all applicable taxes, traveling and any other associated costs.

Kindly send all Technical and Financial Proposal to ATTN:  USP Pakistan Procurement at [email protected] before the closing date April,14th 2021. When submitting your application, write "CE-Mark Certification Training Course - Pakistan" in the email Subject Line.





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